FDA grants breakthrough designation to CLN-081, a targeted therapy for NSCLC with EGFR exon 20 mutations, showing promise in ongoing clinical trials.

The FDA has granted breakthrough therapy designation to CLN-081 for the treatment of certain patients with non-small cell lung cancer (NSCLC) who have EGFR exon 20 insertion mutations and have previously undergone platinum-based chemotherapy. CLN-081, developed by Cullinan Oncology, is an irreversible EGFR inhibitor designed to target cancer cells with the mutation more precisely, while minimizing effects on normal cells with the wild-type EGFR.

Currently, a phase 1/phase 2a clinical trial is assessing various dosages of CLN-081 in NSCLC patients with exon 20 mutations who have seen disease progression after previous treatments. This breakthrough therapy designation is based on the urgent need for more effective targeted treatments for this group of patients and is supported by promising preliminary clinical data.

Cullinan Oncology’s CEO, Nadim Ahmed, expressed satisfaction with the FDA’s recognition, which highlights the critical need for better therapies for these patients. The ongoing clinical study has shown high response rates, durable responses, and promising progression-free survival in heavily pre-treated patients, along with a favorable safety profile. The company looks forward to continuing discussions with the FDA, facilitated by this breakthrough therapy designation.

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