said Tuesday that it has started the withdrawal process of the U.S. marketing authorization for its Blenrep treatment, following the request of the country’s Food and Drug Administration. The pharmaceutical giant said the request comes after its Dreamm-3 Phase 3 study in patients with relapsed or refractory multiple myeloma didn’t meet its primary endpoint of progression-free survival.
The company said patients treated with Blenrep therapy who have been already enrolled in the risk evaluation and mitigation strategy program will have the option to enroll in a compassionate use program to continue to access treatment. “We respect the agency’s approach to the accelerated approval regulations and associated process,” Chief Medical Officer Sabine Luik said. “We will continue the DREAMM clinical trial program and work with the U.S. FDA on a path forward for this important treatment option for patients with multiple myeloma.” Write to Michael Susin at [email protected]