FDA Fast Track Designation for DVX101 (Dilanubicel) for the Treatment of AML
“We are thrilled to receive FT, ODD, and RMAT designations to foster expedited development and approval for our lead clinical asset, dilanubicel, for the treatment of AML,” said Dr. Colleen Delaney, MD, MSc, Chief Science Officer and EVP of Research and Development at Deverra Therapeutics. “I am excited about this added level of commitment and partnership provided by the FDA in granting us this additional designation approval, and we look forward to working closely with the FDA to improve patient outcomes.”
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.
