Cullinan Oncology Gets FDA Breakthrough Designation for CLN-081

By Colin Kellaher

Cullinan Oncology Inc. on Tuesday said the U.S. Food and Drug Administration granted breakthrough-therapy designation to CLN-081 for the treatment of certain patients with non-small cell lung cancer.

The Cambridge, Mass., biopharmaceutical company said the designation covers CLN-081 in patients with locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.

Cullinan is evaluating various doses of CLN-081 in a Phase 1/2a trial in patients harboring exon 20 mutations whose disease has progressed on or after prior therapy.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

01-04-22 0740ET