FDA pushes back decision date on BMS, 2seventy bio's Abecma in earlier line of treatment

It appears Bristol Myers Squibb’s multiple myeloma cell therapy Abecma will not end the year on a happy note. The company’s effort to gain approval for the CAR-T in an earlier line of treatment—previously set for an FDA decision on Dec. 16—will have to be pushed back pending an advisory committee meeting.

BMS revealed on Monday that the FDA’s Oncologic Drug Advisory Committee (ODAC) will meet to discuss data from the KarMMa-3 study. The United States regulator has not identified a date for the meeting, BMS said.

BMS and its partner on the drug, 2seventy bio, said in the release that they expect the meeting has been called to review overall survival (OS) data, which is a secondary endpoint of the phase 3 study. The companies added that the meeting will not impact Abecma’s approval for multiple myeloma as a fifth-line treatment.

This is another blow to the CAR-T medicine, which was hailed as a game-changing treatment upon its approval in March 2021 but has been in commercial decline, with worldwide sales peaking in the first quarter of this year at $147 million but falling to $132 million in the second quarter and $93 million in the third.

The companies have cited manufacturing problems and increased competition from other B-cell maturation antigen receptor (BCMA) products on the market, such as Johnson & Johnson and Legend’s CAR-T Carvykti, which more than doubled its sales year-over-year to $152 million in the third quarter.

In September, 2seventy revealed that it was cutting it headcount by 176, which was 40% of its workforce. The bluebird spinout also moved CEO Nick Leschly to the chairman role and slashed its pipeline. The moves were implemented to stretch the company’s cash runway into 2026.

The companies are anxious to get Abecma approved in an earlier line of treatment to increase its potential patient population and regain its positive trajectory. They have projected Abecma’s peak sales potential at between $2 billion and $3 billion.

In August, the companies said that the KarMMa-3 study met its primary endpoint, showing statistically significant improvement in progression-free survival (PFS). Compared to standard regimens, Abecma reduced the risk of disease progression or death in patients with triple-class exposed relapsed and refractory multiple myeloma.

The companies will present interim OS data on December 11 at the 2023 American Society of Hematology (ASH) annual meeting, they said on Monday.