BRIEF—Breakthrough Therapy designation for Cullinan Oncology

In the USA, Cullinan Oncology has been granted Breakthrough Therapy designation for its lung cancer candidate CLN-081.

The orally available, irreversible EGFR blocker is under development for certain people with locally advanced or metastatic non-small cell lung cancer (NSCLC), following chemotherapy.

Chief executive Nadim Ahmed said: “The updated data from our ongoing Phase I/IIa 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,” he added.