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18-09-2020 | FDA | News

approvalsWatch

Pralsetinib gets FDA go-ahead for RET fusion-positive lung cancer

Author:
Lynda Williams

medwireNews: Pralsetinib may now be given to metastatic non-small-cell lung cancer patients with a confirmed RET fusion, the US FDA has announced.

Use of the RET inhibitor and a companion diagnostic test for the alteration have been given accelerated approval following objective response rate and duration of response rate findings from the ARROW trial of platinum-treated patients with a RET fusion.

Pralsetinib is recommended at a dose of 400 mg once daily taken orally on an empty stomach. The most common adverse reactions are laboratory-measured abnormalities, such as liver enzyme elevations, as well as fatigue, constipation, and musculoskeletal pain.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2020 Springer Healthcare Ltd, part of the Springer Nature Group

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