FDA approval for Carvykti, a CAR-T therapy from Legend Biotech

Legend Biotech (Nasdaq: LEGN), a clinical stage CAR-T immuno-oncology biotech spun out of Hong Kong-listed GenScript Biotech, says that the US Food and Drug Administration has approved its first product, Carvykti (ciltacabtagene autoleucel; cilta-cel), for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Legend Biotech, whose shares edged up around 3% to $39.59 in the news, entered into an exclusive worldwide license and collaboration agreement with US healthcare giant Johnson & Johnson’s (NYSE: JNJ) subsidiary Janssen Biotech, to develop and commercialize cilta-cel in December 2017.

Carvykti is a chimeric antigen receptor T-cell (CAR-T) therapy with two B-cell maturation antigen (BCMA)-targeting single domain antibodies and given as a one-time infusion with a recommended dose range of 0.5 to 1.0 x 106 CAR-positive viable T cells per kg of body weight. In the pivotal CARTITUDE-1 study, deep and durable responses were seen in patients with RRMM (n=97), with a high overall response rate (ORR) of 98% (95% confidence interval [CI]: 92.7-99.7) including 78% of the patients achieving stringent complete response (sCR, 95% CI: 68.8-86.1). At a median of 18 months follow-up, the median duration of response (DOR) was 21.8 months (95% CI 21.8-not estimable).