Allogene Gets FDA Orphan Designation for ALLO-715 in Multiple Myeloma

 Allogene Therapeutics Inc. on Thursday said the U.S. Food and Drug Administration granted orphan-drug designation to ALLO-715 for the treatment of the blood cancer multiple myeloma.

The South San Francisco, Calif., clinical-stage biotechnology company, which previously reported encouraging initial clinical experience in heavily pretreated patients in a Phase 1 study, said it plans to give another update on the study by the end of the year.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.

The agency in April granted ALLO-715 regenerative-medicine-advanced-therapy designation, which offers eligibility for expedited development and regulatory review of product candidates, including earlier and more frequent consultation with the agency, and the potential for accelerated approval.

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