FDA grants breakthrough therapy designation to CLN-081 for lung cancer subset
Click Here to Manage Email Alerts
The FDA granted breakthrough therapy designation to CLN-081 for treatment of certain patients with non-small cell lung cancer.
The designation applies to use of the agent by patients with locally advanced or metastatic EGFR-mutated NSCLC who received prior platinum-based systemic chemotherapy.
CLN-081 (Cullinan Oncology) is an irreversible EGFR inhibitor that selectively targets cells that express EGFR exon 20 insertion mutations while sparing cells that express wild-type EGFR, according to a company-issued press release.
A phase 1/phase 2a trial is underway to evaluate various doses of the agent for patients with NSCLC and exon 20 mutations whose disease progressed on or after prior therapy.
“We are extremely pleased that Cullinan has received breakthrough therapy designation from the FDA for CLN-081, a distinction that underscores the urgent need to bring improved targeted treatments to this patient population and further supports the differentiated clinical profile of CLN-081,” Nadim Ahmed, CEO of Cullinan Oncology, said in the release. “The updated data from our ongoing [phase 1/phase 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. 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.”
Click Here to Manage Email Alerts