New indication in DLBCL in China for Antengene’s Xpovio
China’s National Medical Products Administration (NMPA) has approved Xpovio (selinexor), from Antengene Corp (SEHK: 6996) as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
This follows the drug’s initial approval for the treatment of relapsed/refractory multiple myeloma (R/R MM). Xpovio is licensed from US firm Karyopharm Therapeutics (Nasdaq: KPTI).
The approval of the new indication is supported by data from the registrational SEARCH study in China, Antengene noted. Results from the study, which enrolled a total of 60 Chinese patients with DLBCL, showed that patients treated in the trial achieved a central radiological review assessed overall response rate (ORR) meeting the pre-specified primary endpoint. The SEARCH study demonstrated clear efficacy of orally-administered selinexor monotherapy in Chinese patients, exhibiting significant response rates, durable responses, long survival.
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