The U.S. Food and Drug Administration has granted Fast Track Designation for Genprex Inc.'s (GNPX), lead drug candidate, REQORSA Immunogene Therapy, in combination with Merck & Co's Keytruda in patients with histologically-confirmed unresectable stage III or IV non-small cell lung cancer or NSCLC whose disease progressed after treatment with Keytruda.
In the first quarter of 2022, Genprex expects to initiate its Acclaim-2 trial, which is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Keytruda, for this patient population.
The company previously received its first Fast Track Designation for REQORSA in combination with AstraZeneca PLC's Tagrisso in patients with histologically confirmed unresectable stage III or IV NSCLC, with EGFR mutations that progressed after treatment with Tagrisso.
Fast Track Designation recipients may also be eligible for accelerated approval or rolling review of the recipient's Biologics License Application (BLA) if other qualifying criteria are met. In addition, Fast Track product candidates could be eligible for priority review if supported by clinical data at the time of BLA submission.
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