3.229.117.123
dgid:
enl:
npi:0
FDA Alerts
Hematology
Trending Topics

FDA grants priority review to ide-cel for multiple myeloma

Posted on September 22, 2020

The U.S. Food and Drug Administration has granted priority review to idecabtagene vicleucel ((ide-cel; Bristol Myers Squibb, bluebird bio) for the treatment of patients with multiple myeloma who have received ≥3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, according to a press release.

The FDA has set a goal date of March 27, 2021.

The biologics license application (BLA) is based on results from the pivotal Phase 2 KarMMa study, which included128 adults with heavily pre-treated and highly refractory multiple myeloma, who received ide-cel across the target dose levels of 150-450 x 106 CAR+ T cells after receiving lymphodepleting chemotherapy.

“Today’s Priority Review milestone recognizes the potential of this first anti-BCMA CAR T cell therapy to address a critical unmet need of patients with multiple myeloma,” said Stanley Frankel, MD, senior vice president, Cellular Therapy Development, Bristol Myers Squibb, in a press release. “We are pleased by the significant progress that is being made in partnership with patients and the multiple myeloma community to bring ide-cel to adults with relapsed and refractory multiple myeloma who are triple-class exposed and may benefit from an important new therapeutic option.”

Read the full press release here.

-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-