Therapy Areas: Oncology
GSK releases positive updates on two new cancer drugs
2 December 2022 -

Biopharmaceutical company GSK plc (LSE:GSK) (NYSE:GSK) on Friday announced progress with two of its cancer drugs.

The European Medicines Agency (EMA) has validated GSK's marketing authorisation application for momelotinib, a potential new oral treatment for an uncommon type of bone marrow cancer known as myelofibrosis.

If approved by regulators, momelotinib would be the only medicine that addresses key manifestations of myelofibrosis.

Regulatory action by the Committee for Medicinal Products for Human Use (CHMP) is anticipated by the end of 2023. A New Drug Application for momelotinib is also currently under regulatory review with the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act action date of 16 June 2023.

Separately, GSK announced positive headline results from a phase III trial of Jemperli (dostarlimab) in patients with primary advanced or recurrent endometrial cancer. The trial met its primary endpoint and the treatment showed a "statistically significant and clinically meaningful benefit".

Regulatory submissions based on the trial results are anticipated in the first half of 2023.

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