By Chris Wack


Allogene Therapeutics Inc. said the U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy designation to ALLO-501A in relapsed/refractory Large B Cell Lymphoma.

The company said the RMAT designation was based on the potential of ALLO-501A to address the unmet need for patients who have failed other therapies.

"The designation for ALLO-501A supports the patient need for access to an off-the-shelf CAR T product that can be delivered faster, more reliably, and at greater scale," said Rafael Amado, chief medical officer for Allogene.

RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation. Advantages of the RMAT designation include early interactions with FDA that may be used to discuss potential surrogate or intermediate endpoints and potential ways to satisfy post approval requirements.

Allogene shares were up 4% to $9.86 in premarket trading.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

06-08-22 0859ET