Benzinga | Sep 27, 2021 08:35AM EDT

Atar Biotherapeutics Reports European Medicines Agency Grant For Co.'s Accelerated Assessment Of tab-cel For Treatment Of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease

Designation recognizes therapeutic innovation and potential to address significant unmet patient need

Atara on track to submit MAA in November 2021

Phase 3 ALLELE study analysis supporting tab-cel MAA to be presented in Q4 2021

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (NASDAQ:ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment to the Company's lead product candidate, tabelecleucel (tab-cel(r)), for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).

EBV+ PTLD is a rare and potentially life-threatening cancer that may occur following a solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). For patients with EBV+ PTLD, the median survival is only 2-3 months after failure of initial therapy. There are currently no EMA- or FDA-approved treatments indicated for these patients.

"We believe the granting of accelerated assessment by the EMA recognizes the potential of tab-cel as a first-in-kind new therapy addressing significant unmet need in EBV+ PTLD patients facing poor prognosis with no approved treatment options," said Jakob Dupont, MD, Executive Vice President and Global Head of Research and Development at Atara. "We look forward to working closely with the EMA to bring tab-cel, the first ever allogeneic, off-the-shelf T-cell therapy to be reviewed by a regulatory agency, to patients as quickly as possible."

Accelerated assessment is granted by the CHMP when a medicinal product is expected to be of major public health interest and therapeutic innovation. The CHMP and Committee for Advanced Therapies (CAT) can reduce the time frame to review a marketing authorization application (MAA) to 150 days if the applicant provides sufficient justification for an accelerated assessment, although an application initially designated for accelerated assessment can revert to the standard procedure during the review for a variety of reasons. The decision to grant accelerated assessment has no impact on the eventual CHMP and CAT opinion on whether a marketing authorization should be granted.

Tab-cel also has Orphan Drug status in Europe and was previously granted PRIME designation by the EMA. Following recent successful interactions with the EMA, Atara has completed the necessary regulatory and compliance steps needed to submit an MAA for tab-cel, which is on track for submission in November 2021. With the granting of accelerated assessment, Atara anticipates a decision regarding approval in the second half of 2022.

The MAA submission will include data from the ongoing Phase 3 ALLELE study assessing the efficacy and safety of tab-cel in patients with EBV+ PTLD following solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT).

Atara will present a new analysis from the ALLELE study at an appropriate congress in Q4 2021. Top-line data with additional patients confirm a strong objective response rate (ORR) in line with prior results while demonstrating durability. There were no new safety signals, consistent with previously published findings.