Business
Atara Biotherapeutics Provides Regulatory and Business Update on EBVALLOTM (tabelecleucel)
Atara received FDA Complete Response Letter (CRL) solely related to inspection findings at third-party manufacturer CRL did not identify deficiencies related
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nAtara received FDA Complete Response Letter (CRL) solely related to inspection findings at third-party manufacturer\n\n\nCRL did not identify deficiencies related to clinical efficacy or safety data in the Biologics License Application (BLA), and the FDA did not request any new clinical studies to support approval\n\n\nAtara remains committed to working with the FDA, Pierre Fabre Laboratories, and the third-party manufacturer to bring EBVALLO to patients in the U.S.\n\n\nAtara has engaged a well-known financial advisor to support exploration of all strategic options\n\n\nAtara remains focused on preserving future EBVALLO financial value for the benefit of all stockholders\n\n\nAtara has entered into a non-binding term sheet with Redmile Group to provide up to $15 million in funding, which Atara believes is sufficient to fund the ongoing activities required to achieve BLA approval\n\n\n THOUSAND OAKS, Calif.--(BUSINESS WIRE)--\nAtara 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 it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the EBVALLOTM (tabelecleucel) Biologics License Application (BLA) as monotherapy treatment for 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 including an anti-CD20 containing regimen.\n\n\nThe CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for EBVALLO. The CRL did not identify any deficiencies related to the manufacturing process, the clinical efficacy, or clinical safety data in the BLA, and the FDA did not request any new clinical trials to support the approval of EBVALLO.\n\n\n“We are working closely with our partner Pierre Fabre Laboratories, the FDA, and the third-party manufacturer to address the feedback to support marketing approval for EBVALLO,” said Cokey Nguyen, Ph.D., President and Chief Executive Officer of Atara. “Once the third-party manufacturer GMP compliance issues have been adequately addressed, we will file for a resubmiss...