By Chris Wack
Atara Biotherapeutics Inc. said its Tabelecleucel tab-cel for Post-Transplant Lymphoproliferative Disease is having continued progress with the US Food and Drug Administration, including productive engagement with CBER and a Type B CMC meeting scheduled for the first quarter of 2022.
The company said it plans to complete the Biologics License Application submission for patients with EBV+ PTLD in the second quarter of 2022, and US approval of BLA for patients with EBV+ PTLD anticipated in the first half of 2023.
Atara submitted a Marketing Authorization Application for tab-cel in patients with EBV+ PTLD, the first ever for an allogeneic, off-the-shelf T-cell therapy, in November. With the granting of Accelerated Assessment, the company is looking for a decision regarding EU approval in the fourth quarter.
The company also said the FDA has granted Fast Track designation for ATA188 in non-active primary progressive multiple sclerosis and non-active secondary progressive multiple sclerosis.
Atara said it is continuing to make good progress enrolling the Phase 2 study evaluating the efficacy and safety of ATA188 in patients with progressive MS. The company plans to conduct Phase 3 studies at the conclusion of the Phase 2 study and is actively exploring partnership opportunities.
Atara said it is continuing to advance its CAR T programs in liquid and solid tumors, which include a differentiated approach to allogeneic cell therapy, with no gene editing of the T-cell receptor and next generation CAR technologies to enhance expansion and persistence of functional T cells.
Write to Chris Wack at [email protected]