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FDA Grants Allogene Fast Track Designation for Multiple Myeloma Therapy

June 30, 2021

The U.S. Food and Drug Administration granted Allogene Therapeutics’ ALLO-605, the company’s experimental, next-generation AlloCAR T therapy targeting BCMA, Fast Track designation for the treatment of relapsed or refractory multiple myeloma.

Photo: Rafael Amado, executive vice president of research and development and chief medical officer of Allogene.

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. In 2021, it is estimated that nearly 35,000 people will be diagnosed and more than 12,000 will die from the disease in the United States. While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems, or infections.

ALLO-605 is the company’s first TurboCAR clinical candidate. TurboCAR is a proprietary, next generation platform technology based upon programmable cytokine signaling designed to improve the function and potency of AlloCAR T cells. These properties may also enable CAR T therapy to succeed in solid tumors and increase efficacy in hematologic malignancies. ALLO-605 targets the B-cell maturation antigen (BCMA) for the treatment of patients with relapsed/refractory multiple myeloma and other BCMA-positive malignancies.

Fast Track is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment exists or where the treatment in discovery may be better than what is currently available.

The FDA granted Fast Track designation based on the potential of ALLO-605 to address the unmet need for patients who have failed other standard multiple myeloma therapies. The phase 1 dose escalation portion of the IGNITE trial evaluating ALLO-605 was initiated in the second quarter of 2021.

“With studies now underway for ALLO-715 alone and in combination with a gamma secretase inhibitor, as well as ALLO-605 as our next generation CAR T, we are taking an aggressive three-pronged approach aimed at exploring the unique attributes of AlloCAR T therapies for patients with rapidly progressing disease,” said Rafael Amado, executive vice president of research and development and chief medical officer.

Author: Rare Daily Staff

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