Two supplemental BLAs have been submitted to the FDA for enfortumab vedotin-ejfv to convert its accelerated approval into a regular one and to expand the current label to include patients with locally advanced or metastatic urothelial cancer.
Share this article
Share this article
TOKYO and BOTHELL, Wash., Feb. 18, 2021 /PRNewswire/ Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., Astellas ) and Seagen Inc. (Nasdaq:SGEN) today announced completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for PADCEV
® (enfortumab vedotin-ejfv). One submission, based on the phase 3 EV-301 trial, seeks to convert PADCEV s accelerated approval to regular approval. The second submission, based on the pivotal trial EV-201 s second cohort, requests an expansion of the current label to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are ineligible for cisplatin.
Astellas XOSPATA® (gilteritinib) Receives Conditional Approval by China s National Medical Products Administration for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation
- Accelerated approval follows priority review designation and inclusion in overseas new drugs urgently needed in clinical settings
- XOSPATA® is the first and only FLT3 inhibitor approved by the NMPA for patients with relapsed or refractory AML
News provided by
Share this article
Share this article
TOKYO, Feb. 3, 2021 /PRNewswire/ Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., Astellas ) today announced that the China National Medical Products Administration (NMPA) has granted conditional approval to XOSPATA
Trial PROSPERs China’s fight against advancing prostate cancer
New results from the PROSPER trial helped persuade the Chinese government to approve enzalutamide for adult patients diagnosed with advanced non-metastatic castration-resistant prostate cancer,
Peter Doyle reports
It might be coincidental. But eight months after a joint study by the Peking First University Hospital and National Urological Cancer Center of China in Beijing found a lack of effective therapies in the world’s most populous country for patients with advanced prostate cancer, China’s medicine regulator, the National Medical Products Administration (NMPA), approved the oral androgen-receptor inhibitor enzalutamide for the treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) with high risk of metastasis.