Genprex granted FDA Orphan Drug Designation for Reqorsa in lung cancer

Genprex announced the FDAhas granted Orphan Drug Designation to the company’s lead drug candidate, Reqorsa Immunogene Therapy – quratusugene ozeplasmid -, for the treatment of small cell lung cancer, or SCLC. In addition to ODD for the treatment of SCLC, in June 2023, the FDA granted Fast Track Designation for Reqorsa Immunogene Therapy, in combination with Genentech’s Tecentriq in patients with extensive-stage small cell lung cancer who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. FDA has also granted Genprex FTD for two other indications of Reqorsa Immunogene Therapy, including Reqorsa in combination with Tagrisso for non-small cell lung cancer in patients who have progressed after Tagrisso treatment, and Reqorsa in combination with Keytruda for NSCLC in patients who have progressed after Keytruda treatment.