The FDA has designated the novel EGFR inhibitor CLN-081 breakthrough therapy designation for the treatment of patients with advanced or metastatic EGFR-mutated non-small cell lung cancer, or NSCLC, according to a press release from the manufacturer.
The FDA based the designation on positive results from a phase 1/2a trial.
“The updated data from our ongoing phase 1/2a study in a larger number of patients have demonstrated a high response rate with durable responses and encouraging progression free survival in heavily pre-treated patients,” Nadim Ahmed, Cullinan Oncology CEO, said in a press release. “We are also encouraged by the favorable safety profile observed thus far, and we look forward to ongoing, productive regulatory discussions with the FDA, which are further enabled with this designation.”
Cullinan is looking at multiple different doses of the drug in its clinical trials. CLN-081 is taken orally, and specifically targets cells that express EGFR exon 20 insertion mutations while sparing wild-type cells. It is intended for patients who have either locally advanced or metastatic disease even after first-line treatment with platinum-based chemotherapy.
Photo Credit: Getty Images
