Calithera Biosciences Gets FDA Fast Track For Lung Cancer Drug

By Will Feuer

Calithera Biosciences Inc. said the U.S. Food and Drug Administration has granted fast-track designation for the company's investigational treatment for adults with unresectable or metastatic squamous non-small cell lung cancer.

The FDA's fast-track designation aims to expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need. Drugs with the designation can benefit from early and frequent communication with the agency, in addition to a rolling submission of the marketing application, with potential pathways for expedited approval.

Calithera's mTORC 1/2 inhibitor sapanisertib is meant to treat adults with metastatic squamous non-small cell lung cancer whose tumors have a mutation in nuclear factor erythroid 2-related factor and who have received prior platinum-based chemotherapy and immune checkpoint inhibitor therapy, the company said.

"While there have been significant advances in targeted treatments for lung cancer, little progress has been made specifically for patients with squamous lung cancer," Calithera Chief Executive Susan Molineaux said.

Shares of Calithera rose about 11% in premarket trading to $3.27 a share.

Write to Will Feuer at Will.Feuer@wsj.com

(END) Dow Jones Newswires

October 03, 2022 07:41 ET (11:41 GMT)

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