FDA expands approval for Bristol Myers and 2seventy bio’s Abecma

After a previous delay last November, and a positive AdCom recommendation last month, the US Food and Drug Administration (FDA) has now approved an additional indication for Abecma (idecabtagene vicleucel; ide-cel).

Developed by US pharma major Bristol Myers Squibb (NYSE: BMY) and 2seventy bio (Nasdaq: TSVT), Abecma is now authorized for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial.

The companies noted that the approval expands Abecma’s indication, making it available in earlier lines to patients who have relapsed or become refractory after exposure to these three main classes of treatment (triple-class exposed), after two prior lines of therapy. 2seventy’s shares were up 3.3% at $4.75 in pre-market trading.