Genprex, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the Company's 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 (NSCLC) whose disease progressed after treatment with Keytruda. In the first quarter of 2022, Genprex expects to initiate its Acclaim-2 clinical 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 FTD 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.
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- Genprex Receives U.S. FDA Fast Track Designation for REQORSA™ Immunogene Therapy in Combination With Keytruda® for the Treatment of Non-Small Cell Lung Cancer