Pfizer's (PFE.US) Enfortumab Vedotin has been approved in China for the treatment of multiple myeloma patients.

On March 10, Pfizer (PFE.US) announced that its new drug elranatamab (Enaumab) has officially been approved for marketing in China. It is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Enaumab is a bispecific antibody that targets both BCMA and CD3, and it was granted accelerated approval by the FDA in August 2023 for the treatment of relapsed/refractory MM patients. According to Pfizer, Enaumab was approved based on the clinically meaningful overall response rate and duration of response from the global pivotal Phase 2 single-arm study MagnetisMM-3 and the separate Phase 1b/2 single-arm study MagnetisMM-8 in China. The MagnetisMM-3 clinical study showed that Enaumab monotherapy in triple-refractory RRMM patients demonstrated deep and durable efficacy with a median duration of response (mDOR) not yet reached, a 30-month DOR rate of 61.0%, a median progression-free survival (PFS) of 17.2 months, and a median overall survival (OS) of 24.6 months, without observing any new safety signals. Multiple myeloma (MM) is an incurable blood cancer. Most MM patients will experience disease relapse or treatment resistance, requiring subsequent therapy. Moreover, as the disease progresses, each relapse becomes more invasive, and the duration of remission obtained from new therapies becomes shorter. BCMA is considered an ideal target for the treatment of MM, as it is a member of the TNF receptor superfamily and is mainly expressed in MM cell lines and MM patient cells, with expression increasing with disease progression.