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Three oncology FDA decisions to watch in November 2026

11/4/2026 · 4 min read · updated 4 Nov 2026

Bottom line

These are decision deadlines (PDUFA dates), not approvals. FDA can approve, reject or extend. None of the three drugs is approved in India.

A short note on three oncology applications with FDA target action dates (PDUFA dates) this month. A PDUFA date is the deadline for the FDA to act. It is not an approval: the agency can approve, issue a complete response letter, or extend the review.

Target date Drug (sponsor) Proposed use Key trial
14 Nov 2026 Ivonescimab + platinum doublet (Summit) EGFR-mutated non-squamous NSCLC after a third-generation EGFR TKI HARMONi (phase 3)
27 Nov 2026 Neladalkib (Nuvalent) TKI-pretreated advanced ALK-positive NSCLC (Priority Review) ALKOVE-1 (phase 1/2)
30 Nov 2026 Giredestrant (Roche) Adjuvant ER-positive, HER2-negative stage I–III breast cancer (Priority Review) lidERA (phase 3)

Ivonescimab after osimertinib (14 Nov)

Ivonescimab is a PD-1 × VEGF bispecific antibody. HARMONi compared ivonescimab + platinum doublet with placebo + platinum doublet after progression on a third-generation EGFR TKI. PFS was statistically significant. At the primary OS analysis the HR was 0.79 (95% CI 0.62–1.01; p=0.057), not significant; median OS 16.8 vs 14.0 months. With a June 2026 data cut, the OS HR was 0.76 (95% CI 0.61–0.95; nominal p=0.0151), and 0.76 (0.52–1.10) in Western patients, per Summit.

What to watch: whether FDA accepts a nominal later OS analysis after a non-significant primary one. Ivonescimab is currently approved only in China.

Neladalkib for ALK-positive NSCLC after TKIs (27 Nov)

Neladalkib (NVL-655) is a brain-penetrant, ALK-selective inhibitor designed to stay active against resistance mutations such as G1202R and to avoid TRK-related CNS side effects. In ALKOVE-1, 253 TKI-pretreated patients had a blinded central ORR of 31% (95% CI 26–37%), with 12- and 18-month duration-of-response rates of 64% and 53%. In lorlatinib-naive patients (n=63) ORR was 46%; in G1202R-mutant disease after a prior TKI (n=47) it was 68%. Dose reductions occurred in 17% and discontinuations in 5% at the recommended dose.

What to watch: this is a single-arm filing, so any approval would likely be accelerated. Lorlatinib-pretreated patients are where the need is greatest and where responses were lower.

Adjuvant giredestrant in ER+ early breast cancer (30 Nov)

Giredestrant is an oral SERD. lidERA (n≈4,170, open-label) compared 5 years of giredestrant 30 mg daily with standard tamoxifen or an aromatase inhibitor in medium- or high-risk stage I–III disease. Invasive DFS HR was 0.70 (95% CI 0.57–0.87; p=0.0014); 3-year iDFS 92.4% vs 89.6%. OS was immature. Discontinuation was 5.3% vs 8.2%.

What to watch: this would be the first oral SERD in the curative setting. The absolute gain at 3 years is 2.8 percentage points, follow-up is short for ER-positive disease, and the trial was open-label. A separate giredestrant + everolimus application (evERA, ESR1-mutated advanced disease) is due in December.

For readers in India

An FDA decision does not mean CDSCO approval, availability or affordability here. We will update this note when each decision is announced. See also the October 2026 FDA approvals roundup.

Sources

  1. Summit Therapeutics — FDA accepts ivonescimab BLA in EGFRm NSCLC post-TKI; PDUFA 14 Nov 2026 (29 Jan 2026)
  2. Summit Therapeutics — updated HARMONi overall survival at WCLC 2026 (15 Sep 2026)
  3. Nuvalent — neladalkib NDA accepted with Priority Review; PDUFA 27 Nov 2026 (27 May 2026)
  4. OncLive — ALKOVE-1 top-line efficacy in TKI-pretreated ALK+ NSCLC
  5. Roche — FDA accepts giredestrant NDA in ER+ early breast cancer (lidERA); PDUFA 30 Nov 2026 (2 Jun 2026)
  6. ClinicalTrials.gov — ALKOVE-1 (NCT05384626)
  7. ClinicalTrials.gov — lidERA (NCT04961996)

Educational summary, not medical advice. Opinions are labelled as such and are the author's own. Approvals and availability in India (CDSCO) may differ from the US/EU.

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