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FDA Oncology Approvals and ESMO 2026 Highlights: What Changed in Cancer Care

August–November 2026 update · Written by Dr. Frank Yap, MD · Published and last updated: November 15, 2026
Evidence checked against the FDA oncology approvals page (content current as of November 13, 2026) and ESMO 2026 conference coverage.
QUICK ANSWER
From August 6 to November 13, 2026, the FDA’s oncology approvals page lists 19 new approvals or label expansions. The three with the widest impact were daraxonrasib for previously treated metastatic pancreatic cancer (Aug 26), dostarlimab for MSI-H/dMMR locally advanced rectal cancer (Oct 19, accelerated approval, with a path to avoid surgery for complete responders), and durvalumab plus enfortumab vedotin for cisplatin-ineligible muscle-invasive bladder cancer (Nov 13, about three weeks after the VOLGA data at ESMO). ESMO Congress 2026 (Madrid, October 23–27) was dominated by antibody-drug conjugates, KRAS/RAS inhibitors, bispecific antibodies and individualized mRNA therapy, plus one clear warning: giving checkpoint inhibitors every 12 weeks (MOIO) was linked to worse survival and the trial was stopped early.

1. Ten key takeaways

  • Pancreatic cancer: daraxonrasib (Rasonque) was approved August 26 for previously treated metastatic disease; ESMO subgroup data showed median OS of 13.2 vs 6.7 months (HR 0.40).
  • Rectal cancer: dostarlimab received accelerated approval October 19 for MSI-H/dMMR stage II/III disease, after a real-time review that finished four months ahead of the FDA goal date.
  • Bladder cancer: VOLGA (ESMO LBA2) and the November 13 approval give cisplatin-ineligible or cisplatin-declining patients a new perioperative option, with OS HR 0.58 against cystectomy alone.
  • Small cell lung cancer: DeLLphi-305 showed first-line maintenance tarlatamab plus durvalumab raised median OS to 21.1 vs 12.7 months (HR 0.42); no US label change has been verified yet.
  • Melanoma: INTerpath-001 reported that individualized mRNA therapy (intismeran autogene) plus pembrolizumab cut recurrence-or-death risk by 42% (HR 0.58) in resected stage IIB–IV disease.
  • Lung cancer targeted therapy: divarasib beat sotorasib/adagrasib (PFS 9.8 vs 5.7 months, interim OS HR 0.56) in Krascendo 1, and osimertinib plus savolitinib improved OS in MET-altered, post-osimertinib NSCLC (HR 0.68).
  • ADCs were everywhere: sacituzumab tirumotecan, izalontamab brengitecan, trastuzumab rezetecan, sonesitatug vedotin and others posted large PFS or OS gains, but several trials were run only in China and OS is often immature.
  • De-escalation caution: MOIO (12-weekly checkpoint inhibitors) was stopped early after an unexpected OS imbalance (HR 2.04).
  • Device setback: the FDA issued a not-approvable letter for Novocure’s Optune Mya in NSCLC brain metastases, citing uncertain clinical benefit.
  • Nothing here involves supplements or repurposed drugs. All findings concern conventional or investigational anticancer therapy and should be applied only with a treating oncologist.

2. FDA oncology approvals, August 6 – November 13, 2026

The table below follows the FDA’s own Oncology (Cancer)/Hematologic Malignancies Approval Notifications page, which the agency notes does not announce every label update. Drug names link to the FDA notice. Newest first. Where a trial name or result is shown, it comes from trade-press coverage of the approval and is identified as such.

Genetics vs genomics in cancer, precision oncology diagram

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Date (2026) Agent Indication Notes
Nov 13 Durvalumab (Imfinzi) + enfortumab vedotin-ejfv Neoadjuvant, then adjuvant durvalumab after cystectomy: muscle-invasive bladder cancer, cisplatin-ineligible or refused VOLGA trial. Priority review and Project Orbis. See Section 3.
Nov 10 Pimicotinib (Pimjetmi, EMD Serono) Symptomatic tenosynovial giant cell tumor where surgery may cause functional limitation or severe morbidity Phase 3 MANEUVER; 50 mg once daily (Targeted Oncology).
Nov 5 Amivantamab + hyaluronidase-lpuj (Rybrevant Faspro, Janssen) Recurrent/metastatic head and neck squamous cell carcinoma progressing after platinum chemotherapy and anti-PD-(L)1 (accelerated approval) Not indicated for HPV-associated oropharyngeal SCC. Based on OrigAMI-4 (Targeted Oncology).
Oct 26 Talazoparib (Talzenna, Pfizer) + enzalutamide Metastatic androgen pathway modulation-naïve/-sensitive prostate cancer with HRR gene mutations Requires an FDA-authorized HRR test.
Oct 19 Dostarlimab (Jemperli, GSK) Stage II/III MSI-H/dMMR locally advanced rectal cancer (accelerated approval) AZUR-1, single-arm, n=154. See Section 3.
Oct 16 Pembrolizumab (Keytruda / Keytruda Qlex, Merck) Unresectable or metastatic TMB-H (≥13 mut/Mb) solid tumors, adult and pediatric, after prior treatment with no satisfactory alternative Conversion to traditional approval, with updated indication.
Oct 14 Nogapendekin alfa inbakicept-pmln (Anktiva) + BCG BCG-unresponsive non-muscle-invasive bladder cancer; indication now includes high-grade papillary-only tumors Expanded from the 2024 carcinoma-in-situ indication.
Oct 8 Atezolizumab (Tecentriq; Tecentriq Hybreza) + fluoropyrimidine and oxaliplatin Adjuvant treatment of stage III dMMR colon cancer Different from dostarlimab: this is adjuvant therapy combined with chemotherapy.
Oct 7 Tucatinib (Tukysa, Pfizer/Seagen) + trastuzumab + pertuzumab Maintenance of unresectable locally advanced or metastatic HER2-positive breast cancer after induction HER2CLIMB-05: median PFS 24.9 vs 16.3 months (Targeted Oncology).
Oct 2 Pirtobrutinib (Jaypirca, Lilly) Previously untreated CLL/SLL with no known 17p deletion First-line use of a non-covalent BTK inhibitor.
Sep 24 Belzutifan (Welireg) + lenvatinib Advanced clear-cell RCC after a PD-1/PD-L1 inhibitor Note: ESMO LITESPARK-012 (Section 8) was a different, negative combination.
Sep 23 Lirafugratinib (Lyrfigtu, Elevar) Previously treated cholangiocarcinoma with FGFR2 fusion or rearrangement Kinase inhibitor.
Sep 18 Imlunestrant (Inluriyo) + abemaciclib (Lilly) ER+/HER2− ESR1-mutated advanced breast cancer after at least one endocrine therapy Requires FDA-authorized ESR1 test.
Sep 9 Sevabertinib (Hyrnuo, Bayer) Non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations (accelerated approval) Listing no longer restricts to previously treated patients, unlike the November 2025 notice.
Sep 4 Camizestrant (Etcamah, AstraZeneca) + CDK4/6 inhibitor HR+/HER2− advanced breast cancer when an ESR1 mutation is detected during aromatase inhibitor + CDK4/6 inhibitor therapy (accelerated approval) Used with abemaciclib, palbociclib or ribociclib.
Aug 26 Daraxonrasib (Rasonque, Revolution Medicines) Metastatic pancreatic adenocarcinoma after at least one prior systemic therapy, or not a candidate for multiagent therapy RASolute 302. See Section 3.
Aug 25 Zanidatamab-hrii (Ziihera) ± tislelizumab-jsgr (Tevimbra) + chemotherapy First-line HER2-positive unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma HERIZON-GEA-01; updated OS shown at ESMO (Section 7).
Aug 13 Iberdomide (Zenbexus, BMS) + daratumumab/hyaluronidase-fihj + dexamethasone Multiple myeloma after at least one prior line including a proteasome inhibitor and an immunomodulatory agent (accelerated approval) New oral agent combination.
Aug 6 Vusolimogene oderparepvec-wtpg (Tudriqev, Replimune) + nivolumab Unresectable advanced cutaneous melanoma progressing on a PD-1-blocking regimen (accelerated approval) Genetically modified oncolytic viral therapy.

Also on November 11, 2026, the FDA approved the PCR-based OncoMate MSI Dx Analysis System as a companion diagnostic to identify MSI-H solid tumors for pembrolizumab (Targeted Oncology’s November FDA brief).

3. Three FDA approvals explained

3.1 Dostarlimab for MSI-H/dMMR locally advanced rectal cancer (October 19)

The FDA granted accelerated approval to dostarlimab (Jemperli, GSK) for adults with stage II/III locally advanced rectal cancer that is MSI-H or dMMR, as determined by an FDA-authorized test. The dose is 500 mg IV every three weeks for up to nine cycles.

  • Pivotal data: AZUR-1 is a multicenter, single-arm trial of 154 previously untreated patients. Of these, 110 (71%) were treated with dostarlimab alone, received no other treatment and did not progress; 26 (17%) had surgery; 13 (8%) received additional systemic therapy or radiation.
  • Primary endpoint: sustained clinical complete response for 12 months (cCR12). Per the FDA, cCR12 was 47% by independent central review among 116 evaluable patients and 68% by investigator assessment among 144. A further 33% of independently reviewed cCRs had less than 12 months’ follow-up at data cutoff, which helps explain the gap.
  • Response rate: ORR 79% by independent review and 82% by investigators.
  • Follow-up: at a median of 26.3 months, none of the patients with cCR12, cCR or near-complete response had progressed. Of 15 patients who had surgery after dostarlimab alone because imaging suggested an incomplete response, 12 had a pathologic complete response.
  • Supporting study: the FDA also reviewed an investigator-led single-arm study (NCT04165772, 50 patients) with a cCR12 rate of 93%.
  • Process: reviewed under Real-Time Oncology Review and Project Orbis, part of the Commissioner’s National Priority Voucher pilot, and approved four months ahead of the goal date. At ESMO 2026, the first AZUR-1 results were presented as a late-breaking abstract (LBA87).
  • Safety: labeling carries warnings for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic stem cell transplant, and embryo-fetal toxicity.
Why the wording matters
This is an accelerated approval based on a single-arm trial, so continued approval depends on confirmatory evidence. Non-operative management requires close surveillance (every 4 months for two years, then every 6 months in AZUR-1), and patients who do not reach a complete response still need standard rectal cancer treatment. Do not confuse this with the October 8 atezolizumab approval, which is adjuvant therapy for stage III dMMR colon cancer given together with chemotherapy.

3.2 Durvalumab plus enfortumab vedotin for cisplatin-ineligible MIBC (November 13)

The FDA approved perioperative durvalumab (Imfinzi) with neoadjuvant enfortumab vedotin-ejfv (Padcev): three neoadjuvant cycles, radical cystectomy, then up to nine cycles of adjuvant durvalumab, for adults with muscle-invasive bladder cancer who are ineligible for or refuse cisplatin-based chemotherapy. AstraZeneca’s application received priority review in September 2026.

  • Evidence (VOLGA, n=695, randomized, open-label): 24-month event-free survival 63.5% vs 45.1% (HR 0.51); 24-month OS 78.4% vs 69.4% (HR 0.58) against radical cystectomy alone. At ESMO, pathologic complete response was 45% vs 10%.
  • Triplet arm: adding tremelimumab improved EFS (HR 0.61) but not OS at interim analysis (HR 0.77, not significant) with more toxicity; it was not part of the approval.
  • Safety: trade-press coverage of the approval reports grade 3 or higher adverse events of any cause in 71.1% vs 50.2%. Enfortumab vedotin carries risks of skin reactions, peripheral neuropathy, hyperglycemia, ocular disorders and pneumonitis; durvalumab carries immune-mediated reactions.
  • Context: enfortumab vedotin plus pembrolizumab was approved for cisplatin-ineligible MIBC on November 21, 2025 and expanded on July 10, 2026 to all MIBC patients who are cystectomy candidates, so oncologists now have two ADC-plus-checkpoint options in this setting.
  • ctDNA signal (exploratory, n=112): 60% of baseline-positive patients cleared ctDNA before surgery, and their 24-month EFS was 81% vs 55% for those with persistent positivity.

3.3 Daraxonrasib for previously treated metastatic pancreatic cancer (August 26)

The FDA approved daraxonrasib (Rasonque), a RAS-family inhibitor, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. At ESMO 2026 (abstract LBA82), additional RASolute 302 analyses reported median OS of 13.2 vs 6.7 months with chemotherapy (HR 0.40; 95% CI 0.30–0.53), with consistent benefit across RAS genotype subgroups, including regardless of identified RAS mutation status, and across chemotherapy regimens and prior treatment settings.

Related first-line (RASolute 303) and adjuvant (RASolute 304) studies are ongoing and have not produced approvals; this article does not report results for them.

4. Pending FDA decisions and setbacks

Item Status Detail
Rivoceranib + camrelizumab, first-line HCC PDUFA date April 9, 2027 Resubmitted October 13, 2026; described as the fourth FDA submission for this indication.
Gedatolisib, PIK3CA-mutated HR+/HER2− breast cancer sNDA accepted; PDUFA June 25, 2027 Based on VIKTORIA-1. Gedatolisib with fulvestrant ± palbociclib was already approved July 14, 2026 for patients without a PIK3CA mutation.
Zipalertinib + platinum chemotherapy, first-line EGFR exon 20 NSCLC NDA completed (November 13) Based on phase 3 REZILIENT3 progression-free survival data.
Optune Mya (Novocure), NSCLC brain metastases Not-approvable letter (November 11) FDA cited uncertain clinical benefit; no safety concerns were raised.
Temab-A (telisotuzumab adizutecan) Two breakthrough therapy designations (October 8) Colorectal cancer and c-Met-expressing lung cancer.
Fast track designations, October 2026 Nine investigational agents Include opamtistomig (biliary tract cancer), SBE303 (Nectin-4 ADC, post-enfortumab urothelial cancer), PSV359 (FAP alpha therapy) and QTX3034 (multi-KRAS inhibitor with cetuximab).

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Designations (breakthrough, fast track, orphan, RMAT) speed development; they are not approvals and say nothing about whether a drug works.

5. ESMO Congress 2026 at a glance

The European Society for Medical Oncology Congress took place in Madrid, October 23–27, 2026. Three Presidential Symposia carried twelve late-breaking phase 3 abstracts (LBA1–LBA12), with many more late-breakers in tumor-specific sessions. Seven themes stood out:

  • Antibody-drug conjugates: TROP2 (sacituzumab tirumotecan), HER2 (trastuzumab rezetecan, TQB2102), EGFR/HER3 bispecific (izalontamab brengitecan), CLDN18.2 (sonesitatug vedotin), B7-H3 (risvutatug rezetecan), c-Met and others.
  • RAS-pathway inhibitors: daraxonrasib subgroup data and divarasib versus approved KRAS G12C inhibitors.
  • Bispecific antibodies: tarlatamab (DLL3 × CD3) and ivonescimab (PD-1 × VEGF).
  • Individualized mRNA therapy: the first phase 3 INTerpath-001 results.
  • Biomarker-guided and ctDNA strategies: MET-selected NSCLC, CLDN18.2 gastric cancer, ctDNA clearance in bladder cancer.
  • Immunotherapy-sparing in dMMR disease: dostarlimab alone in rectal cancer, pembrolizumab alone in endometrial cancer.
  • De-escalation tested, and failing: 12-weekly checkpoint inhibitor dosing (MOIO).
How to read late-breaking data
Late-breaking abstracts are first presentations. Many report interim overall survival, some trials were run only in China, and several were open-label. A conference result is not a label change. Section 9 separates what is FDA-approved from what remains data only.

6. Presidential Symposia, trial by trial

Evidence tier column: see Section 13. “L1” = randomized phase 3 trial. HR = hazard ratio; PFS = progression-free survival; OS = overall survival; EFS = event-free survival; RFS = recurrence-free survival.

Presidential Symposium I (melanoma, bladder, SCLC, prostate)

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LBA Trial and setting Regimen vs control Key efficacy Key safety Tier
LBA1 INTerpath-001 (n=1,137). Resected stage IIB–IV melanoma Intismeran autogene (individualized mRNA) + pembrolizumab vs placebo + pembrolizumab RFS HR 0.58 (0.45–0.75); 24-mo RFS 82.2% vs 70.0%; DMFS HR 0.62; OS HR 0.77, immature. No separation in first 6 months, then HR 0.42 Grade 3–5 AEs 23.6% vs 20.3%; discontinuation 16.6% vs 9.5%; pyrexia 52.2% vs 8.2% L1
LBA2 VOLGA (n=695). Cisplatin-ineligible/refusing MIBC Neoadjuvant durvalumab + enfortumab vedotin → cystectomy → adjuvant durvalumab vs cystectomy alone EFS HR 0.51 (0.38–0.67); OS HR 0.58 (0.40–0.83); pCR 45% vs 10% Grade 3/4 AEs 64% vs 44%; immune-mediated AEs 33% vs 3% L1; FDA-approved Nov 13
LBA3 DeLLphi-305 (n=563). ES-SCLC maintenance after platinum-etoposide-durvalumab Tarlatamab + durvalumab vs durvalumab Median OS 21.1 vs 12.7 mo (HR 0.42); PFS 7.4 vs 1.9 mo (HR 0.34); ORR 26.4% vs 4.1% CRS 49.6% (one grade 3); ICANS 1.1%; grade ≥3 AEs 46.8% vs 40.6% L1; interim OS (61% information)
LBA4 DASL-HiCaP (n=1,106). Very high-risk localized prostate cancer Darolutamide + 96 weeks ADT + radiotherapy vs placebo MFS by conventional imaging HR 0.42 (0.27–0.66); 4-yr MFS 95% vs 88%; OS HR 0.88, not significant Flushing 66% vs 64%; fatigue 64% vs 57% L1; interim

Presidential Symposium II (lung, gastroesophageal, biliary)

LBA Trial and setting Regimen vs control Key efficacy Key safety Tier
LBA5 Krascendo 1 (n=338). Previously treated KRAS G12C NSCLC Divarasib vs sotorasib or adagrasib PFS 9.8 vs 5.7 mo (HR 0.58); interim OS 17.7 vs 12.0 mo (HR 0.56); ORR 58.4% vs 32.3% Grade 3/4 TRAEs 24.6% vs 34.5%; diarrhea 66% vs 38%; no TRAE deaths L1; interim OS
LBA6 SAFFRON (n=338). EGFR-mutant NSCLC, MET overexpression/amplification, after osimertinib Osimertinib + savolitinib vs platinum-pemetrexed PFS 7.6 vs 5.4 mo (HR 0.55); OS 17.8 vs 12.9 mo (HR 0.68); ORR 51% vs 27% Fatal AEs 7% vs 0 (one treatment-related); peripheral edema 49% vs 8% L1
LBA7 CLARITY-Gastric01 (n=594 randomized). Previously treated CLDN18.2+ gastroesophageal carcinoma Sonesitatug vedotin vs investigator’s choice 3L+ OS 10.0 vs 5.0 mo (HR 0.47); ITT OS 10.6 vs 6.4 mo (HR 0.58); ITT BICR-PFS HR 0.77, P=.053 (missed) Grade ≥3 AEs 52.9% vs 61.1%; nausea 54.4% vs 26.6% L1; dual primary partly missed
LBA8 HARMONi-GI1 (n=682, China). First-line advanced biliary tract cancer Ivonescimab + gemcitabine/cisplatin vs durvalumab + gemcitabine/cisplatin OS 14.9 vs 12.1 mo (HR 0.75); PFS 8.4 vs 5.8 mo (HR 0.61); ORR 53.8% vs 32.5% Grade 3/4 AEs 82.0% vs 72.3% L1; interim; China-only

Presidential Symposium III (sarcoma, immunotherapy dosing, endometrial)

LBA Trial and setting Regimen vs control Key efficacy Key safety Tier
LBA9 ARTEMIS-011 (n=122, China). Relapsed/refractory osteosarcoma Risvutatug rezetecan (B7-H3 ADC) vs gemcitabine + docetaxel PFS 5.5 vs 1.4 mo (HR 0.33); ORR 15% vs 2%; OS immature (HR 0.51, CI 0.21–1.23) Grade ≥3 TRAEs 93% vs 83%; serious TRAEs 64% vs 29%; no fatal TRAEs L1; small, short follow-up (7.1 mo)
LBA10 MOIO (n=340). Responding advanced solid tumors on checkpoint inhibitors ICI every 12 weeks vs standard schedule PFS HR 1.35 (non-inferiority not shown); deaths 19.9% vs 10.5% (OS HR 2.04); stopped early AE rates similar L1; negative, terminated early
LBA11 TroFuse-005 (n=776). Endometrial cancer after platinum and PD-(L)1 Sacituzumab tirumotecan vs doxorubicin or paclitaxel PFS 7.2 vs 3.9 mo (HR 0.59); OS 19.0 vs 12.1 mo (HR 0.68); ORR 35.1% vs 17.3% Grade ≥3 TRAEs 54.4% vs 41.4%; stomatitis 57.0%; ocular surface toxicity 30.5% L1
LBA12 KEYNOTE-C93 (n=299). First-line dMMR endometrial cancer Pembrolizumab alone vs carboplatin + paclitaxel PFS 38.2 vs 8.4 mo (HR 0.57); OS HR 0.77, not significant (high IO crossover) Grade ≥3 TRAEs 18.1% vs 50.7% L1; did not test chemo-immunotherapy standard

7. Other late-breaking data by tumor type

Lung cancer

Trial Setting and regimen Result Tier / note
OptiTROP-Lung06 (n=455) First-line PD-L1-negative non-squamous NSCLC: sac-TMT + pembrolizumab vs chemotherapy + pembrolizumab PFS 15.0 vs 5.7 mo (HR 0.49); ORR similar (50.2% vs 47.3%); OS immature (HR 0.58) L1; published in NEJM
OptiTROP-Lung04 (n=376) EGFR-mutant NSCLC after EGFR TKI: sac-TMT vs platinum chemotherapy Final OS 25.9 vs 17.4 mo (HR 0.69); adjusted for later ADC use, HR 0.57 L1
PANKU-Lung01 (n=432) EGFR-mutant NSCLC after third-generation TKI: iza-bren vs platinum chemotherapy PFS 11.1 vs 5.7 mo (HR 0.40); grade ≥3 TRAEs 78.7% vs 62.1% L1; interim; published in The Lancet
PERSEE (n=321) First-line PD-L1 ≥50% NSCLC: pembrolizumab + chemotherapy vs pembrolizumab PFS 16.1 vs 6.9 mo (HR 0.56); OS 50.2 vs 29.9 mo (HR 0.77, not significant, not powered); grade ≥3 TRAEs 54% vs 19% L1
ROSETTA Lung-107 (n=30 evaluable) Post-chemoimmunotherapy NSCLC: pumitamig (PD-L1 × VEGF-A) + docetaxel ORR 36.7%; DCR 90%; median PFS 6.9 mo at 12-week median follow-up L4; phase 2, very early

Breast cancer

Trial Setting and regimen Result Tier / note
NATALEE 6-year (HR+/HER2− stage II–III) Adjuvant ribociclib + aromatase inhibitor vs aromatase inhibitor alone OS HR 0.809 (0.661–0.989); absolute OS benefit 2.1% at 6 years; iDFS HR 0.741, absolute 5.3% at 6 years; no new safety signals L1; OS benefit modest in absolute terms
HORIZON-Breast06 (n=551) HER2-low advanced breast cancer: trastuzumab rezetecan vs chemotherapy PFS 16.4 vs 6.8 mo (HR 0.27); ORR 75.5% vs 41.2%; ILD 2.5% L1; OS immature; China
APEX-Breast01 (n=543) HER2-low: TQB2102 (biparatopic HER2 ADC) vs chemotherapy PFS 16.4 vs 5.5 mo (HR 0.29); ILD 2.2% L1; interim; China
PANKU-Breast01 (n=383) Pretreated HR+/HER2−: iza-bren vs chemotherapy PFS 8.18 vs 4.01 mo (HR 0.41); ORR 40.5% vs 20.2% L1; OS immature; China
KEYNOTE-B49 (n=342) HR+/HER2− CPS ≥1: pembrolizumab + chemotherapy vs placebo + chemotherapy PFS HR 0.74, but OS HR 1.04 (no difference) L1; PFS-only gain

Gastrointestinal cancers

Trial Setting and regimen Result Tier / note
RASolute 302 subgroups Previously treated metastatic pancreatic cancer: daraxonrasib vs chemotherapy Median OS 13.2 vs 6.7 mo (HR 0.40); consistent across RAS genotypes L1; FDA-approved Aug 26
AZUR-1 (n=154) dMMR/MSI-H locally advanced rectal cancer: dostarlimab alone High clinical complete response rate; see Section 3.1 for FDA-reported figures L4; FDA accelerated approval Oct 19
CheckMate 8HW final OS MSI-H/dMMR metastatic colorectal cancer: nivolumab + ipilimumab First-line OS HR 0.37 vs chemotherapy (79.8% of chemotherapy patients later got immunotherapy); across lines, combination vs nivolumab OS HR 0.61; 5-yr OS 77% vs 66% in first line L1; first-line combo vs nivolumab comparison missed the prespecified threshold
G-HOPE-001 Previously treated gastric/GEJ: arcotatug tavatecan vs physician’s choice PFS HR 0.45; ORR 37.4% vs 7.7%; roughly 43% lower risk of death at the September 2026 interim analysis L1; interim
HERIZON-GEA-01 (updated) First-line HER2+ gastroesophageal adenocarcinoma: zanidatamab + chemotherapy ± tislelizumab vs trastuzumab + chemotherapy OS 22.9 vs 19.6 mo (HR 0.76); triplet 27.0 mo (HR 0.65; 3-yr OS 40% vs 23%) L1; FDA-approved Aug 25; arms not compared head-to-head

Kidney and other

LITESPARK-012 (advanced kidney cancer) reported that adding belzutifan or quavonlimab to pembrolizumab plus lenvatinib did not improve survival, so lenvatinib plus pembrolizumab remains the frontline benchmark in that trial’s setting (Targeted Oncology coverage). I have not independently reviewed the full dataset.

8. Negative, mixed and cautionary results

Good evidence reviews report what failed as clearly as what succeeded. Eight results from ESMO 2026 deserve a caution label:

Trial What happened Why it matters
MOIO 12-weekly checkpoint inhibitors: PFS non-inferiority not shown; deaths 19.9% vs 10.5% (HR 2.04); accrual stopped in selected subgroups April 10 and entirely May 5, 2026 The investigators advised returning to standard dosing and said the data cannot support 12-week dosing. De-escalation needs trials, not assumption.
KEYNOTE-B49 Pembrolizumab + chemotherapy in HR+/HER2− breast cancer improved PFS (HR 0.74) but OS was unchanged (HR 1.04) A PFS gain without survival benefit and with 11.2% vs 5.4% treatment discontinuation.
CLARITY-Gastric01 ITT BICR-PFS narrowly missed significance (P=.053) though OS doubled in 3L+ Dual primary endpoints were only partly met.
SAFFRON Fatal adverse events in 7% (12 patients) vs none with chemotherapy; one treatment-related Survival gain came with toxicity and edema (49%).
KEYNOTE-C93 PFS improved but OS not significant; trial did not compare against chemotherapy plus immunotherapy Investigator’s own conclusion: not equivalent to the current standard; an option for selected dMMR patients avoiding chemotherapy.
PERSEE Adding chemotherapy to pembrolizumab raised grade ≥3 TRAEs from 19% to 54%; OS not significantly different Benefit is PFS-driven and costly in toxicity.
DASL-HiCaP MFS benefit but no significant OS difference at interim (HR 0.88) Metastasis-free survival is an accepted surrogate here, but OS remains unproven.
Optune Mya (FDA) Not-approvable letter in NSCLC brain metastases, citing uncertain clinical benefit Shows the FDA will withhold approval over unproven benefit even when safety is acceptable.

9. From conference to label: what is approved vs data only

Agent / regimen ESMO 2026 data US regulatory status (as verified)
Durvalumab + enfortumab vedotin (VOLGA) LBA2, Oct 24 Approved Nov 13, 2026 (cisplatin-ineligible/refusing MIBC)
Dostarlimab, rectal (AZUR-1) LBA87 Accelerated approval Oct 19, 2026, before the congress presentation
Daraxonrasib, pancreatic (RASolute 302) LBA82 subgroups Approved Aug 26, 2026
Zanidatamab ± tislelizumab (HERIZON-GEA-01) LBA79 updated OS Approved Aug 25, 2026
Tarlatamab + durvalumab maintenance (DeLLphi-305) LBA3 First-line maintenance use: no approval verified in this review. (Tarlatamab received traditional approval for previously treated ES-SCLC on Nov 19, 2025.)
Intismeran autogene + pembrolizumab (INTerpath-001) LBA1 No approval verified in this review
Divarasib (Krascendo 1) LBA5 No approval verified in this review
Osimertinib + savolitinib (SAFFRON) LBA6 No approval verified in this review
Sacituzumab tirumotecan (TroFuse-005, OptiTROP trials) LBA11 and lung abstracts No approval verified in this review
Iza-bren, trastuzumab rezetecan, TQB2102, sonesitatug vedotin, ivonescimab (HARMONi-GI1), risvutatug rezetecan LBA6–LBA9, breast and lung abstracts No US approval verified in this review; several trials China-only

“No approval verified” means I did not find an FDA approval notice in the sources reviewed. It does not prove that no application is pending. Check the FDA notifications page for updates.

10. Biomarker checklist for 2026

Many of this year’s advances are biomarker-gated. If you or a family member has cancer, ask whether the tumor has been tested for the following:

Biomarker 2026 development Status
MSI-H / dMMR Dostarlimab (rectal), atezolizumab (adjuvant colon), CheckMate 8HW (metastatic CRC), KEYNOTE-C93 (endometrial); OncoMate MSI Dx companion diagnostic approved Nov 11 FDA-approved (rectal, colon); data (others)
TMB-high (≥13 mut/Mb) Pembrolizumab traditional approval, Oct 16 FDA-approved
RAS / KRAS (pancreatic) Daraxonrasib, Aug 26 FDA-approved
KRAS G12C (lung) Divarasib beat sotorasib/adagrasib in Krascendo 1 Data only
HER2 (breast, gastric, NSCLC TKD) Tucatinib maintenance, zanidatamab, sevabertinib; ADCs in HER2-low FDA-approved (first three); data (ADCs)
ESR1 mutation (breast) Camizestrant + CDK4/6i (Sep 4); imlunestrant + abemaciclib (Sep 18) FDA-approved
HRR gene mutations (prostate) Talazoparib + enzalutamide, Oct 26 FDA-approved
FGFR2 fusion (cholangiocarcinoma) Lirafugratinib, Sep 23 FDA-approved
MET overexpression/amplification Osimertinib + savolitinib after osimertinib (SAFFRON) Data only
CLDN18.2 Sonesitatug vedotin (CLARITY-Gastric01) Data only
ctDNA / MRD VOLGA exploratory ctDNA clearance; atezolizumab for ctDNA-MRD-positive MIBC approved May 15, 2026 FDA-approved (MIBC MRD); exploratory (VOLGA)

11. What this means for patients and families

  • Ask for comprehensive biomarker testing before and during treatment, because several 2026 approvals depend on it and some require an FDA-authorized test.
  • Ask whether a newer option exists in your setting. For example, a patient with MSI-H/dMMR rectal cancer may now be a candidate for immunotherapy alone, with surgery reserved for incomplete responders.
  • Look at absolute benefit, not only hazard ratios. NATALEE’s 6-year OS benefit is 2.1 percentage points; VOLGA’s 24-month OS difference is about 9 points.
  • Be cautious about treatment de-intensification outside a trial. MOIO is the reminder.
  • Understand interim and surrogate endpoints. PFS, MFS, cCR and pCR are not the same as living longer.
  • Complementary or integrative care (nutrition, exercise, symptom support) can sit alongside standard treatment, but none of the trials above tested supplements or repurposed drugs, and nothing here supports replacing or delaying an effective therapy. Tell your oncology team about everything you take.

12. How the evidence is tiered

Tier Definition used here Examples in this article
CEBM Level 1 (L1) Randomized phase 3 trial; interim or immature OS is flagged in the table VOLGA, DeLLphi-305, Krascendo 1, TroFuse-005, MOIO (negative)
CEBM Level 2 Randomized phase 2 or post-hoc/subgroup analyses of randomized trials RASolute 302 subgroup analyses (the pivotal trial itself is Level 1)
CEBM Level 4 (L4) Single-arm trials and case series AZUR-1, ROSETTA Lung-107
CEBM Level 5 Expert opinion, mechanism, preclinical Not used for conclusions here
Regulatory grade FDA approval notice on the FDA site All entries in Section 2

Limits of this review: I relied on FDA notices and professional trade-press recaps of the ESMO presentations rather than the full abstracts or publications. Numbers are as presented at the congress and may change in peer-reviewed publication. Trial-level details I could not confirm are omitted rather than estimated.

13. AI personalization guide

Use an AI assistant to turn this article into questions for your oncology visit. Do not use any assistant to choose or change a treatment. Paste the relevant section of this article for context and verify claims on the FDA page.

Claude
Best for: Plain-language explanation and structured question lists
“Here is a section of an article on 2026 FDA oncology approvals. My family member has [cancer type, stage, biomarkers if known]. Explain in plain language which items might be relevant, what each result does and does not prove, and give me ten questions to ask the oncologist.”
ChatGPT
Best for: Comparing options and drafting a visit summary
“Using the table of FDA approvals below, make a one-page summary for a [cancer type] appointment that separates FDA-approved options from ESMO data that is not yet approved. Flag which entries depend on a biomarker test.”
Gemini
Best for: Cross-checking against Google-indexed sources and trial listings
“Check whether the FDA approvals in this article are still current and list any newer oncology approvals since November 13, 2026. Cite the FDA page for each.”
Perplexity
Best for: Fast sourced look-ups
“Find the FDA notice and the original ESMO 2026 abstract for [trial name] and report the primary endpoint, comparator, and whether overall survival is mature.”

14. Frequently asked questions

What did the FDA approve in oncology between August and mid-November 2026?
The FDA’s oncology approval notifications list 19 approvals or label expansions from August 6 to November 13, 2026. They include daraxonrasib for previously treated metastatic pancreatic cancer (August 26), zanidatamab-based first-line therapy for HER2-positive gastric/GEJ/esophageal adenocarcinoma (August 25), dostarlimab for MSI-H/dMMR locally advanced rectal cancer (October 19, accelerated approval), talazoparib plus enzalutamide for HRR-mutated metastatic prostate cancer (October 26), and durvalumab plus enfortumab vedotin for cisplatin-ineligible muscle-invasive bladder cancer (November 13).
Does dostarlimab replace surgery for rectal cancer?
Not universally. The October 19, 2026 accelerated approval covers adults with stage II/III MSI-H/dMMR locally advanced rectal cancer identified by an FDA-authorized test. In the single-arm AZUR-1 trial (154 patients), 71% were treated with dostarlimab alone without further treatment or progression, and the FDA-reported 12-month sustained clinical complete response rate was 47% by independent review and 68% by investigators. Patients who do not achieve a complete response still need standard care, and accelerated approval means confirmatory evidence is still required.
What was the most important result at ESMO Congress 2026?
There was no single winner. The Presidential Symposia reported positive phase 3 results for individualized mRNA therapy plus pembrolizumab in resected melanoma (INTerpath-001, RFS HR 0.58), perioperative durvalumab plus enfortumab vedotin in bladder cancer (VOLGA, OS HR 0.58), maintenance tarlatamab plus durvalumab in extensive-stage small cell lung cancer (DeLLphi-305, OS HR 0.42), divarasib in KRAS G12C lung cancer (Krascendo 1), and several antibody-drug conjugates. The FDA acted on VOLGA within three weeks.
Did any ESMO 2026 trial show that a treatment approach could cause harm?
Yes. The phase 3 MOIO trial tested giving immune checkpoint inhibitors every 12 weeks instead of on the standard schedule in responding patients. It did not show non-inferiority for progression-free survival (HR 1.35) and deaths were 19.9% versus 10.5% (HR 2.04), so enrollment was stopped early. The investigators stated the results cannot support using 12-week dosing outside a trial.
What is daraxonrasib and who can receive it?
Daraxonrasib (Rasonque, Revolution Medicines) is an inhibitor of the RAS GTPase family. The FDA approved it on August 26, 2026 for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. At ESMO 2026, additional RASolute 302 analyses reported median overall survival of 13.2 versus 6.7 months with chemotherapy (HR 0.40), with benefit seen regardless of RAS mutation status.
Are ESMO late-breaking results peer-reviewed and available to patients now?
Late-breaking abstracts are presented at the congress and are often published later or simultaneously. Some ESMO 2026 trials appeared in journals alongside the presentation, while others are conference-only. A positive presentation does not mean the drug is approved. Only the FDA approvals listed in this article have changed US labels, and regional availability in Malaysia, Singapore or elsewhere depends on local regulators.
Do any of these FDA approvals or ESMO trials test supplements or repurposed drugs?
No. Every approval and trial summarized here evaluated conventional or investigational anticancer agents, devices or companion diagnostics. Nothing in this article supports a supplement or repurposed-drug claim, and readers should discuss any complementary approach with their treating oncologist because of possible interactions and delays to effective treatment.

15. Sources

16. Medical disclaimer and disclosures

MEDICAL DISCLAIMER
This article is for general education and is not medical advice, diagnosis or treatment. Cancer treatment decisions must be made with a qualified oncologist who knows the patient’s full history, biomarkers and goals. Do not start, stop or change treatment based on this article.

Editorial note: Approval dates, indications and trial figures were compiled on November 15, 2026 from the sources listed above. Regulatory status can change quickly; verify on the FDA website before relying on any entry. ESMO figures are from conference presentations and may differ from later peer-reviewed publications.

Written by Dr. Frank Yap, MD for OneDayMD.com. Last updated November 15, 2026.
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