PDUFA Dates: November 2026

Non-small cell lung cancer driven by EGFR mutations, after the disease has progressed on a targeted TKI — a point where durable options run thin.

Ivonescimab is a bispecific antibody that targets both PD-1 and VEGF in a single molecule, and Summit Therapeutics is filing it in combination with chemotherapy. It is aimed at patients whose EGFR-mutated, non-squamous non-small cell lung cancer has progressed after an EGFR-targeted TKI — a setting of real unmet need once targeted therapy stops working. The BLA is built on the Phase III HARMONi trial and holds FDA Fast Track designation, with a November 14 target action date. Lung cancer is one of oncology's largest and most contested markets. Watch the breadth of the approved label and how ivonescimab is positioned against standard chemotherapy in this post-TKI population.

ALK-positive non-small cell lung cancer that has stopped responding to prior ALK inhibitors, including disease that has spread to the brain.

Neladalkib is an investigational ALK-selective, brain-penetrant inhibitor for patients whose ALK-positive NSCLC has progressed on earlier targeted therapy. Resistance and spread to the central nervous system are the two problems that limit today's ALK drugs, and a selective, brain-penetrant molecule is designed to address both. Nuvalent's NDA was accepted with Priority Review on the strength of the global, registration-directed ALKOVE-1 Phase 1/2 trial in TKI pre-treated patients, with a November 27 target action date. ALK-positive disease is a small but well-defined molecular subset of lung cancer, and the post-TKI setting is where new options are most needed. Watch the depth and durability of responses, especially intracranial activity.

IgA nephropathy — a progressive autoimmune kidney disease that, left unchecked, can advance toward kidney failure.

Povetacicept is an engineered dual inhibitor of BAFF and APRIL, two signals that drive the antibody-producing B cells implicated in IgA nephropathy; blocking both aims further upstream than single-pathway approaches. Vertex filed the BLA under the accelerated approval pathway, supported by the prespecified Week-36 interim of the Phase 3 RAINIER trial. The program holds Breakthrough Therapy designation, and the roughly six-month review window is consistent with priority handling, pointing to a November 30 target date. Approval would mark Vertex's move into nephrology, beyond its established cystic-fibrosis and pain franchises. Watch the strength of the Week-36 interim and the confirmatory-trial design that accelerated approval will hinge on.

Early-stage, ER-positive/HER2-negative breast cancer — the most common breast cancer subtype — in the post-surgery adjuvant setting, where the goal is preventing recurrence.

Giredestrant is an oral selective estrogen receptor degrader (SERD). Per Genentech, it is the first oral SERD to post positive Phase 3 results in the curative, adjuvant setting, based on the lidERA trial — a notable distinction, since earlier oral SERD wins came in advanced or metastatic disease. The proposed indication is adjuvant treatment of ER-positive, HER2-negative stage I-III early breast cancer, the largest breast cancer population. The FDA accepted the NDA under Priority Review with a November 30 target date. This is separate from a second giredestrant NDA — with everolimus, in ESR1-mutated advanced disease — that carries its own separate decision later in 2026. Watch how recurrence-risk subgroups are defined in any label.