FDA monthly preview: Key November decisions to watch

Upcoming FDA decisions span cancer, cardiovascular disease, rare genetic disorders, and more.

By
Mouj Hijazi
October 29, 2026
7 min

MDSpire News

Overview

The article lists anticipated FDA action dates in November 2026 for applications spanning sickle cell disease, lung and breast cancers, gastrointestinal stromal tumors, hypertrophic cardiomyopathy, and type 3 Gaucher disease. The applications include investigational therapies and a supplemental filing for an already approved therapy; the article reports trial findings for several submissions but does not report FDA decisions.

Background

Prescription Drug User Fee Act (PDUFA) dates are target dates for FDA action on submitted applications. The November preview describes applications at different stages of review, including filings granted Priority Review and one therapy with prior Breakthrough Therapy designation. The submissions address conditions across hematology, oncology, cardiology, and neurology. Related monthly previews cover other anticipated regulatory decisions, while the supplied web context identifies current oncology guidance and practice recommendations for sickle cell gene therapy.

Data Highlights

Therapy	Indication and application	Target FDA action date	Reported supporting evidence
Mitapivat (Pyrukynd)	Supplemental application for sickle cell disease; Priority Review and accelerated approval pathway	November 1, 2026	Phase 3 RISE UP evaluated hemoglobin response and annualized sickle cell pain crises; phase 3 REIGNITE is evaluating transfusion burden.
Ivonescimab	With chemotherapy for EGFR-mutated locally advanced or metastatic nonsquamous NSCLC after TKI treatment	November 14, 2026	Supported by phase 3 HARMONi, comparing ivonescimab plus chemotherapy with placebo plus chemotherapy after a third-generation EGFR inhibitor.
Neladalkib	TKI-pretreated advanced ALK-positive NSCLC; Priority Review	November 27, 2026	Supported by TKI-pretreated patients in the phase 1/2 ALKOVE-1 trial; previously received Breakthrough Therapy and Orphan Drug designations.
Giredestrant	Adjuvant treatment for adults with ER-positive, HER2-negative stage I–III breast cancer; Priority Review	November 30, 2026	In phase 3 lidERA, invasive disease recurrence or death risk was reduced by 30% versus standard endocrine therapy; 3-year invasive disease-free survival was 92.4% versus 89.6%.
Bezuclastinib plus sunitinib	Gastrointestinal stromal tumors after prior imatinib; Priority Review	November 30, 2026	In phase 3 PEAK, median progression-free survival was 16.5 versus 9.2 months and objective response rates were 46% versus 26%, compared with sunitinib alone.
Aficamten (Myqorzo)	Supplemental application for adults with symptomatic obstructive hypertrophic cardiomyopathy	November 14, 2026	Review is based on phase 3 MAPLE-HCM, which compared aficamten monotherapy directly with metoprolol.
Venglustat	Type 3 Gaucher disease; Priority Review	November 25, 2026	Phase 3 LEAP2MONO met both primary endpoints for ataxia (SARA) and neurocognitive performance (RBANS) at week 52.

Key Findings

Agios reported a November 1, 2026, PDUFA goal date for mitapivat’s supplemental application for sickle cell disease; the FDA accepted it for Priority Review under the accelerated approval pathway.
Summit Therapeutics reported a November 14 target date for ivonescimab plus chemotherapy in EGFR-mutated advanced nonsquamous NSCLC after TKI treatment; the application is supported by phase 3 HARMONi.
Nuvalent reported a November 27 target date for neladalkib in TKI-pretreated advanced ALK-positive NSCLC; the FDA accepted the application for filing and granted Priority Review.
Roche reported a November 30 goal date for adjuvant giredestrant in ER-positive, HER2-negative stage I–III breast cancer. In phase 3 lidERA, 3-year invasive disease-free survival was 92.4% with giredestrant and 89.6% with standard endocrine therapy.
Cogent Biosciences reported a November 30 goal date for bezuclastinib plus sunitinib after imatinib-treated gastrointestinal stromal tumors. In phase 3 PEAK, median progression-free survival was 16.5 months versus 9.2 months with sunitinib alone.
Sanofi reported a November 25 target date for venglustat in type 3 Gaucher disease; the phase 3 LEAP2MONO study met its SARA and RBANS primary endpoints at week 52. Separately, the supplied practice-recommendation reference addresses delivery of sickle cell gene therapy, including center preparedness, patient selection, conditioning, and long-term follow-up.

Clinical Implications

The listed dates and trial results describe pending regulatory reviews, not FDA determinations; the article does not establish whether any application will be approved. For clinical context, the supplied ASTCT/ISCT practice-recommendation reference addresses implementation and follow-up considerations for sickle cell gene therapy, a distinct treatment approach from mitapivat.

Conclusion

November 2026 includes anticipated FDA action dates across several disease areas, with supporting evidence ranging from phase 3 comparative outcomes to ongoing trials. Regulatory outcomes remain pending in the source article.