Friday, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted positively (8-3) favoring expanded use of Bristol Myers Squibb & Co BMY 2seventy bio Inc’s TSVT Abecma (idecabtagene vicleucel).
The panel said Abecma demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on the pivotal Phase 3 KarMMa-3 study results, including the key secondary endpoint of overall survival.
The FDA will consider the recommendation from the ODAC during its ongoing review of the supplemental Biologics License Application (sBLA) for Abecma for this patient population.
The FDA has not yet assigned a new target action date for the review of the sBLA, which was postponed from the target action date of December 16, 2023.
Abecma was recently approved in Japan and Switzerland for patients with relapsed and/or refractory multiple myeloma who have received at least two prior therapies based on the KarMMa-3 study, making it the first CAR T cell therapy to receive regulatory approval for use in earlier lines of therapy for patients with relapsed or refractory multiple myeloma.
Abecma also received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency for the extension of indication to include triple-class exposed relapsed and refractory multiple myeloma after at least two prior therapies.
Concurrently, on Friday, the ODAC panel discussed the review of Johnson & Johnson JNJ/Legend Biotech Corporation’s (NASDAQ: LEGN Carvykti in second-line multiple myeloma based on the CARTITUDE-4 trial.
FDA ODAC unanimously votes 11 to 0, supporting the favorable risk-benefit assessment of Carvykti based on results from the Phase 3 CARTITUDE-4 study.
A supplemental Biologics License Application supported by the CARTITUDE-4 study is currently under review by the FDA with a Prescription Drug User Fee Act date of April 5, 2024.
William Blair expects that both CAR-T therapies are likely to receive approval based on the positive voting trends.
This could widen Abecma’s market potential and potentially lead to its growth. However, competition from Carvykti and bispecifics is expected to constrain Abecma’s total market opportunity despite these advancements.
Read Next: Bristol Myers’ Breyanzi Scores Second FDA Approval For Blood Cancer Therapy.
Price Action: JNJ shares are down 0.51% at $157.39, LEGN stock is up 0.03% at $64.04, and BMY stock is down 1.04% at $51.81 on the last check Monday. TSVT shares are up 15.20% at $4.62.
Image by PDPics from Pixabay
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