lungs

FDA grants orphan drug designation to Genprex’s Reqorsa

Betsy Goodfellow | August 15, 2023 | News story | Medical Communications FDA, ODD, Oncology, Reqorsa 

Gene therapy company Genprex has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead candidate Reqorsa Immunogene Therapy (quratusugene ozeplasmid), for the treatment of patients with small cell lung cancer (SCLC).

The FDA previously granted the drug Fast Track Designation (FTD) when used in combination with Genentech’s Tecentriq in patients with extensive-stage small cell lung cancer (ES-SCLC) who did not develop tumour progression after receiving Tecentriq with chemotherapy as an initial treatment.

The company also received FTD for two further indications for Reqorsa, including in combination with Tagrisso for non-small cell lung cancer (NSCLC) and in combination with Keytruda for NSCLC patients who have progressed after initial treatment with Keytruda.

Rodney Varner, president, chairman and chief executive officer at Genprex, commented: “We are excited to receive ODD from the FDA for Reqorsa for patients with SCLC. This FDA ODD in combination with our recently received FDA FTD underscores the great need for better treatment options for patients with SCLC, ES-SCLC and NSCLC. We look forward to initiating the Acclaim-3 clinical trial expected in the fourth quarter of 2023 in order to bring hope of an effective new therapy to patients suffering with this life-limiting cancer.”

Betsy Goodfellow

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