FDA grants RMAT and fast track status to Allogene's cema-cel

Allogene Therapeutics (NASDAQ: ALLO) announced that the U.S. Food and Drug Administration has granted both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations to cemacabtagene ansegedleucel (cema-cel) for the treatment of adult patients with large B-cell lymphoma (LBCL) who test positive for minimal residual disease (MRD) following first-line therapy.

The FDA based the RMAT designation on interim data from the ongoing pivotal ALPHA3 trial. At a protocol-defined data cutoff, 58.3% (7 of 12) of patients in the cema-cel arm achieved MRD negativity, compared with 16.7% (2 of 12) in the observation arm — a 41.6% absolute difference. The cema-cel arm also showed a 97.7% median decrease in plasma circulating tumor DNA at Day 45, versus a 26.6% median increase in the observation arm.

The ALPHA3 trial enrolls patients in remission following first-line chemoimmunotherapy who test positive for MRD using Natera's CLARITY MRD assay. Enrolled patients are assigned to receive either a single dose of cema-cel or observation, the current standard of care.

As of the data cutoff, cema-cel was reported to be well-tolerated with no treatment-related serious adverse events, no cases of cytokine release syndrome, neurotoxicity, graft-versus-host disease, or high-grade infections, and no patient hospitalizations for treatment-related adverse events.

"The FDA's decision to grant both RMAT and Fast Track designations provides additional validation for the strategy we defined with the ALPHA3 trial," said Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene Therapeutics.

RMAT designation is intended to expedite development and review of regenerative medicine therapies for serious or life-threatening conditions where preliminary clinical evidence indicates potential to address an unmet medical need. Fast Track designation may provide eligibility for rolling review and priority review if relevant criteria are met.

Cema-cel was developed based on a license from Cellectis granted to Servier, which subsequently granted Allogene exclusive rights in the U.S., all EU member states, and the United Kingdom. The information above is based on a press release from Allogene Therapeutics.

You May Also Be Interested In

• FDA grants emergency use for Simparica TRIO to treat screwworm in dogs
• Alpha Cognition reports Q2 2026 revenue of $6M as net loss narrows
• Datasea Inc. (DTSS) files $150M mixed shelf