The conditional approval was based on the P-Ib/II (CARTITUDE-1) study evaluating Carvykti in patients (n=97) with r/r multiple myeloma who have received 3 prior lines of treatment incl. PI, IMiD & anti-CD38 mAb
The results showed a median duration of 18mos. follow up, deep & durable responses on one-time treatment, patients with CI (98%) & sCR (80%). The safety profile of Carvykti was evaluated on patients (n=179) in the (MMY2001) & (MMY2003) trials
Carvykti is a BCMA-directed genetically modified autologous T-cell immunotherapy that can reprogramme a patient’s T-cells with a transgene encoding CAR which identifies & eliminates BCMA-expressing cells. Additionally, Carvykti was approved by the US FDA on Feb’22
Ref: Businesswire | Image: Legend
