The U.S. Food and Drug Administration (FDA) recently granted Fast Track Designation (FTD) for REQORSA Immunogene Therapy for patients with extensive-stage small cell lung cancer (ES-SCLC).
AUSTIN, TX / ACCESSWIRE / July 11, 2023 / The U.S. Food and Drug Administration (FDA) recently granted Fast Track Designation (FTD) for REQORSA® Immunogene Therapy for patients with extensive-stage small cell lung cancer (ES-SCLC).
The FDA typically awards FTD if it determines that non-clinical or clinical data demonstrate the potential for a drug to address an unmet medical need for a serious or life-threatening disease or condition. The objective is to facilitate the development and expedited review of such drugs so that they can reach the market expeditiously if approved.
REQORSA is the lead drug candidate from Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. The study will administer the drug in combination with Genentech, Inc.'s Tecentriq® in patients who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment.
In the third quarter of 2023, Genprex expects to enroll the first patient in its Acclaim-3 clinical trial, which is a Phase 1/2 dose escalation and clinical response study of maintenance therapy evaluating REQORSA in combination with Tecentriq for this patient population. The company has previously received two other FTDs for REQORSA in combination with AstraZeneca PLC’s Tagrisso® and with Merck and Co’s Keytuda®.
The company stated, “We are very pleased to receive a third Fast Track Designation from the FDA for REQORSA, this time for patients with ES-SCLC in combination with the checkpoint inhibitor Tecentriq,” said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex. “This is another exciting achievement in our REQORSA development program, which further validates REQORSA’s potential not only in NSCLC but also in SCLC. We look forward to accelerating the clinical development of REQORSA, and potentially providing a new treatment option for patients with SCLC.”
Featured photo by Louis Reed on Unsplash.
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SOURCE: Genprex
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