PDUFA Dates: October 2026

Previously treated extensive-stage small cell lung cancer — an aggressive cancer that almost always returns after first-line platinum chemotherapy, leaving few effective options.

Ifinatamab deruxtecan is the first B7-H3-directed antibody-drug conjugate submitted to the FDA. It links an antibody against B7-H3 — a protein broadly overexpressed on small cell lung cancer — to Daiichi Sankyo's deruxtecan (DXd) topoisomerase-I-inhibitor payload, the same platform behind Enhertu. Discovered by Daiichi Sankyo and co-developed with Merck, it targets adults whose ES-SCLC has progressed on or after platinum-based chemotherapy, a setting with poor second-line outcomes. The FDA granted Priority Review, Breakthrough Therapy, and Orphan Drug status, and is reviewing it under Real-Time Oncology Review and Project Orbis. Watch the October 10 target action date — approval would deliver the first B7-H3-directed ADC.

Chronic weight management in adults with obesity, or overweight plus at least one weight-related complication — a market reshaped by GLP-1 medicines and still expanding fast.

CagriSema is Novo Nordisk's fixed-dose combination of cagrilintide, a long-acting amylin analog, and semaglutide, the GLP-1 receptor agonist behind Wegovy and Ozempic. The two hormones curb appetite through complementary pathways, and pairing them is Novo's bid to push weight loss beyond what semaglutide delivers alone — and to answer Eli Lilly's tirzepatide. Novo filed the NDA in December 2025 for adults with obesity, or overweight with at least one comorbidity, at the 2.4 mg cagrilintide plus 2.4 mg semaglutide dose. Note that Novo has not disclosed a specific FDA action date, saying only that review is expected during 2026. As the next major obesity launch in the pipeline, this is a decision to watch.

Stage III colon cancer with deficient mismatch repair (dMMR/MSI-H) — tumors removed by surgery but at high risk of returning, where immunotherapy has had no established adjuvant role.

Genentech is seeking to add Tecentriq (atezolizumab), its PD-L1 checkpoint inhibitor, to standard FOLFOX chemotherapy as adjuvant — post-surgery — treatment for stage III dMMR/MSI-H colon cancer. Mismatch-repair-deficient tumors respond especially well to immunotherapy, but checkpoint inhibitors have been used mainly in metastatic disease; this sBLA would move that benefit earlier, into the curative-intent setting. The pivotal Phase 3 ATOMIC trial showed a 50% reduction in the risk of recurrence or death. The FDA granted Priority Review, with a target action date of October 9. If approved, it would establish a new adjuvant standard for this molecularly defined subgroup of colon cancer patients.

Recurrent respiratory papillomatosis in adults — a rare HPV-driven disease that grows wart-like tumors in the airway, forcing patients into repeated surgeries to keep breathing.

INO-3107 is INOVIO's DNA immunotherapy — a plasmid-based medicine designed to drive a targeted T-cell response against the HPV strains that cause recurrent respiratory papillomatosis. Standard care today is repeated surgery to remove growths from the airway; there is no FDA-approved drug therapy for the disease, so a medicine that reduces the surgical burden would be a meaningful first. The FDA granted Breakthrough Therapy and Orphan Drug designations. One caveat to watch: the BLA was filed under the accelerated-approval pathway, and the FDA's acceptance letter flagged a preliminary view that INOVIO has not yet submitted adequate information to justify accelerated-approval eligibility. The target action date is October 30.