FDA delays its decision on earlier Abecma treatment for RRMM

Similar applications under review in EU, Switzerland, Japan

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The U.S. Food and Drug Administration (FDA) is delaying its review of an application that seeks to allow the cell therapy Abecma (idecabtagene vicleucel) to be used earlier in the treatment of difficult-to-manage multiple myeloma.

Abecma currently is FDA-approved for adults with relapsed or refractory multiple myeloma (RRMM) who have had at least four previous lines of therapy, including at least one immunomodulatory drug, one proteasome inhibitor, and one CD38 inhibitor.

Earlier this year, the regulatory agency agreed to review an application seeking to expand the therapy’s use for patients who have received each of these three standard therapy classes. Similar applications are under review in the European Union, Switzerland, and Japan.

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FDA decision had been expected by Dec. 16

The FDA was expected to make a decision by Dec. 16, which has now been delayed, according to a press release from Abecma’s developers Bristol Myers Squibb (BMS) and 2seventy bio.

The companies did not say whether a new decision date has been set, but noted the FDA will convene its Oncologic Drugs Advisory Committee (ODAC), a group of experts in the field of cancer, to review data from the application, although no date was disclosed.

BMS and 2seventy expect the meeting will focus mainly on discussions of overall survival data from the Phase 3 KarMMa-3 clinical trial (NCT03651128). Data from the trial formed the basis for the applications to the FDA and other regulatory agencies.

The companies “look forward to continuing discussions with the FDA and participating in the ODAC meeting to reinforce the potential of Abecma to deliver significantly improved outcomes in patients with triple-class exposed RRMM in earlier lines of treatment,” the release stated. “The ODAC meeting has no impact on the currently approved indication for Abecma for adult patients with triple-class exposed RRMM after four or more prior lines of therapy.”

Abecma is a CAR T-cell therapy that involves collecting immune cells called T-cells from a patient, engineering them to be better at killing cancer cells, then infusing them back into the patient.

The KarMMa-3 study included 386 adults with RRMM who had received two to four prior treatment regimens including an immunomodulatory drug, a proteasome inhibitor, and the CD38 inhibitor Darzalex (daratumumab). Participants were treated with either Abecma or one of five standard combination treatments.

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Earlier results showed Abecma reduced risk of disease progression, death

Results, published earlier this year, showed Abecma prolonged, by about threefold, progression-free survival, or the time patients lived without signs of disease progression, relative to standard regimens, meeting the trial’s main goal. This reflected a 51% reduced risk of disease progression or death.

In addition, a significantly greater proportion of patients responded to Abecma compared with standard treatments (71% vs. 42%), achieving one of the study’s key secondary goals. At the time, data on overall survival — the other key secondary goal — could not yet be reliably calculated as most patients were still alive.

KarMMa-3’s final progression-free survival results and interim overall survival data will be presented at the 2023 American Society of Hematology Annual Meeting and Exposition, to be held Dec. 9-12, in San Diego, California, and online.