$Atara Biotherapeutics (ATRA.US)$ NEWS Atara Biotherapeutics...
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Atara Biotherapeutics Submits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA
05/20/2024 - 06:25 AM First Allogeneic T-Cell Therapy BLA Submission to U.S. Food and Drug Administration If Approved, Tab-cel Would be First Approved Therapy in U.S. for EBV+ PTLD Acceptance of BLA Will Trigger $20 Million Milestone Payment from Pierre Fabre Laboratories, with Potential for Additional $60 Million Milestone Upon FDA Approval THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that Atara has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tabelecleucel (tab-cel®) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. There are no FDA approved therapies in this treatment setting.
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