FDA red and green lights: September 2024

Oncology approvals are picking up again, with seven in September. A couple of these were eagerly awaited, subcutaneous Tecentriq having missed its original 2023 PDUFA date on manufacturing issues, and Novartis recently disclosing a three-month delay for Kisqali in adjuvant breast cancer. Another nod came ahead of time; a decision on AstraZeneca’s Tagrisso in stage III EGFR-mutated NSCLC hadn’t been expected until the end of the year. There had been some doubts about this use, given the high level of crossover in the supporting Laura trial, which raised questions about the best time to give Tagrisso. The green light suggests that the FDA didn’t share these concerns. Tagrisso made $5.8bn in 2023, and Astra sees stage III disease as a blockbuster use. Johnson & Johnson also faces questions about the best setting for its EGFR x cMet bispecific Rybrevant, which is now approved for EGFRm NSCLC in both the first (alongside Lazcluze) and second line (with chemo). Elsewhere, Sanofi’s Sarclisa is set for a battle with its CD38-rival, J&J/Genmab’s Darzalex, in transplant-ineligible first-line multiple myeloma. Sarclisa bagged approval for a Velcade, Revlimid and dexamethasone quadruplet last month, but J&J just filed Darzalex based on data from the Cepheus trial.

Selected September 2024 US regulatory decisions in oncology

Note: VRd=Velcade, Revlimid + dexamethasone. Source: OncologyPipeline.