RE:RE:RE:RE:ONCY pelareorep + CD3 bispecific antibody true-killer comboAugust 11, 2023 - FDA Approves J&J's Second Multiple Myeloma Bispecific Antibody Johnson & Johnson took the fast track for its latest cancer drug. J&J’s subsidiary Janssen Pharmaceutical announced Thursday its bispecific antibody has won accelerated approval from the FDA for relapsed or refractory multiple myeloma.
J&J’s first-in-class antibody Talvey (talquetamab-tgvs) is bispecific, binding to the CD3 receptor on the T cell surface to a receptor expressed on the myeloma cells to bring them together, allowing the body’s immune system to kill the cancer.
The accelerated approval was based on a Phase II study. An overall response rate of 73.6% was seen in patients with at least four prior lines of therapy, including a bispecific antibody or CAR-T cell therapy. Response was durable for a median of 9.5 months in the lower dosing group. Median duration of response was not yet reached in the higher dose arm.
This is the second bispecific antibody for multiple myeloma to hit the market from J&J’s Janssen. Approved last fall, Tecvayli is also a fifth line, subcutaneous treatment that targets the same receptor on the T-cell and the BCMA expressed on the surface of the cancer cells.
https://www.biospace.com/article/j-and-j-snags-fda-approval-for-second-multiple-myeloma-bispecific-antibody-/