FDA approves first BCMA-targeted CAR-T cell therapy

In the KarMMa study involving 128 RRMM patients, the ORR to a single infusion of Abecma was 73%, with a CR rate of 33%.

“In the KarMMa study involving 128 patients with RRMM, the overall response rate (ORR) to a single infusion of Abecma was 73%, with a complete response (CR) rate of 33%.”

Abecma has demonstrated the ability to induce rapid, deep, and long-lasting remissions with just one infusion.

“Abecma has demonstrated the ability to induce rapid, deep, and long-lasting remissions with just one infusion, providing a new and effective personalized therapy option for MM patients [227, 243, 258, 259].”

The median duration of response to Abecma was 11 months in patients achieving CR and 19 months in those achieving sCR.

“The median duration of response (mDOR) was 11 months in patients achieving CR and 19 months in those achieving stringent complete response (sCR).”

Two BCMA-directed CAR-T products, Abecma and Carvykti, were approved by the FDA for RRMM patients who underwent four or more prior lines of therapy in 2021 and 2022, respectively.

“Two BCMA-directed CAR-T products, Abecma and Carvykti, have been approved by the FDA for the treatment of RRMM patients who underwent four or more prior lines of therapy in 2021 and 2022, respectively [227, 228].”

Common side effects of Abecma such as CRS and ICANS were mostly low grade.

“Common side effects such as CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) were mostly low grade, indicating manageable toxicity.”