FDA Grants Breakthrough Therapy Designation for Cullinan Oncology’s CLN-081 in Patients With Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
Cullinan Oncology, Inc. recently announced the US FDA has granted Breakthrough Therapy Designation for CLN-081 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor (EGFR) exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy.
“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,” said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology. “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. 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.”
Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
CLN-081 is an orally available, irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild type EGFR. Cullinan is evaluating various doses of CLN-081 in a Phase 1/2a trial in patients with NSCLC harboring exon 20 mutations whose disease has progressed on or after prior therapy.
Cullinan Oncology is a biopharmaceutical company that is developing a diversified pipeline of targeted therapeutic candidates across multiple modalities in order to bring important medicines to cancer patients. The company’s strategy is to source innovation through both internal discovery efforts and external collaborations, focusing on advanced stage assets with novel technology platforms and differentiated mechanisms. For more information, visit www.cullinanoncology.com.
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