Merus Gets US FDA Approval for Bizengri in Advanced Pancreatic, Lung Cancers

MT Newswires Live12-05

Merus (MRUS) said late Wednesday that the US Food and Drug Administration has approved Bizengri for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma or non-small cell lung cancer with a neuregulin 1, or NRG1, gene fusion, who have progressed after prior systemic therapy.

These indications have been approved under accelerated approval, with continued approval contingent on confirmatory trial results, the company said.

The approval is based on eNRGy trial results, which showed a 40% overall response rate in pancreatic cancer patients and 33% in NSCLC, the company said, adding that the drug showed a duration of response ranging from 3.7 to 16.6 months in pancreatic cancer and a median of 7.4 months in NSCLC.

Bizengri is expected to be available to patients in the coming weeks, the company added.

Shares of the company were up 1.8% in recent after-hours activity.

Price: 46.32, Change: +0.83, Percent Change: +1.84

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