Elevation Oncology Gets Fast Track Designation for Seribantumab to Treat Tumors Harboring NRG1 Gene Fusions

By Chris Wack

Elevation Oncology Inc. said Wednesday that the U.S. Food and Drug Administration has granted fast track designation to seribantumab to treat tumors.

Seribantumab for the tumor-agnostic treatment of advanced solid tumors that harbor neuregulin-1 gene fusions is being evaluated in a Phase 2 study. The initial data from the study will be presented in June, the company said.

"There are currently no approved therapies that specifically target NRG1 fusions, and therefore, receipt of Fast Track designation in a tumor-agnostic setting is a significant step in addressing this unmet need," said Chief Executive Shawn M. Leland.

Fast track is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives fast track designation is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval.

Elevation Oncology shares were up 14% to $4.01 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

May 25, 2022 07:56 ET (11:56 GMT)

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