Positive FDA AdCom votes for cell therapies Abecma and Carvykti

Two meeting of the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) held on Friday resulted in recommendations for approval of two cell therapies – Abecma (idecabtagene vicleucel) and Carvykti (ciltacabtagene autoleucel.

First up, there was good news for US pharma major Bristol Myers Squibb (NYSE: BMY) and its partner 2seventy bio (Nasdaq; TSVT), with the latter‘s shares rocketing almost 30% to $1.19, as the ODAC voted positively (8-3) that Abecma demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on results from the pivotal Phase III KarMMa-3 study, including the key secondary endpoint of overall survival.

The recommendation from the ODAC will be considered by the FDA during its ongoing review of the supplemental Biologics License Application (sBLA) for Abcema for this patient population. The FDA has not yet assigned a new target action date for review of the sBLA.