PDUFA Action Date Extension Announced for Revumenib NDA for R/R KMT2Ar Acute Leukemia; new PDUFA action date: Dec 26, 2024
“Revumenib, upon approval, will be the first drug indicated to treat patients with KMT2A-rearranged acute leukemia, a population with significant unmet need,” said Michael A. Metzger, Chief Executive Officer. “We are confident that the data from the AUGMENT-101 trial, as well as the additional information provided to the FDA, support approval and continue to demonstrate the meaningful benefit revumenib brings to patients with this devastating disease. We look forward to continuing our engagement with the FDA as they complete their review of the NDA by December 26, 2024.”
Share:
More News
“Cancer, a leading cause of death worldwide, exacts an immense toll on individuals, families, and communities. No person, family, scientist, clinician, hospital, policy maker, company or country can or should face this devastating disease alone. We all must work together to win, which is why we are committed to playing
“Our encouraging Phase 2 data for GRANITE in MSS-CRC continue to mature and demonstrate durable benefit over time. With two additional months of follow-up, relative progression-free survival has further improved in the analysis of all patients treated with GRANITE, and most notably, in those with a lower tumor burden at
“Patients in the EU with ROS1 -positive non-small cell lung cancer and NTRK -positive solid tumors face a great unmet need for new therapies that may improve their outcomes and address or delay the difficult issue of treatment resistance,” said Joseph Fiore, vice president, global program lead, repotrectinib, Bristol Myers
“The acquisition of Biotheus builds on our successful ongoing collaboration on BNT327/PM8002 and other investigational bispecific antibodies,” said Prof. Ugur Sahin, M.D., Ph.D., CEO and co-founder of BioNTech. “We believe that BNT327/PM8002 has the potential to set a new standard of care in multiple oncology indications, surpassing traditional checkpoint inhibitors.
