Genprex Receives U.S. FDA Fast Track Designation for REQORSA™ in Combination With Keytruda® for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

Jul 18 2025

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Genprex Receives U.S. FDA Fast Track Designation for REQORSA™ in Combination With Keytruda® for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

Genprex, Inc., today announced that the U.S. Food and Drug Administration (FDA) had 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.

Source: Genprex, Inc.

Non-Small Cell Lung Cancer (NSCLC) is the most common form of lung cancer. Early-stage NSCLC accounts for approximately 18% of the cases. Most of these patients are treated with curative intent and often require multimodality therapy. Despite these aggressive measures, the survival associated with NSCLC is less than optimal, with a 5-year overall survival (OS) ranging from 50% for stage IA disease to 15% for stage IIIA NSCLC.

  • Several clinical trials have demonstrated improved survival with postoperative chemotherapy in selected patients who undergo complete surgical resection. Available evidence supports the use of adjuvant chemotherapy for stage II and stage IIIA, but not for stage IA NSCLC.

However, the current Non-Small Cell Lung Cancer (NSCLC) treatment market share, market uptake, attribute analysis concerning the most potential emerging therapies (DS-1062a, NovoTTF-200T, Nivolumab, REGN2810, MEDI4736, etc.) have been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for Non-Small Cell Lung Cancer (NSCLC) treatment. The key companies in the advanced development stage are Daiichi Sankyo, Inc., NovoCure GmbH, Bristol-Myers Squibb, Regeneron Pharmaceuticals, AstraZeneca, etc.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook report on Non-Small Cell Lung Cancer (NSCLC) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2020 to 2030.

Thelansis specializes in pharmaceutical market research and market Insight Report Company, published reports across the therapeutic area, including rare / ultra-rare and mainstream indication. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

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