GSK reports regulatory progress for Omjjara, Jemperli

(Sharecast News) - GSK announced on Monday that it has received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for 'Omjjara', or momelotinib, as a treatment for myelofibrosis. The FTSE 100 pharmaceuticals giant described Omjjara is a once-daily, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor.

It said the approval was based on data from the pivotal phase three 'MOMENTUM' and 'SIMPLIFY-1' trials.

The approval was the fourth major one for momelotinib, following previous authorisations from the US Food and Drug Administration, the European Commission, and the Medicines and Healthcare products Regulatory Agency in the UK.

In a separate development, GSK also announced that the European Medicines Agency (EMA) had accepted its application to expand the use of 'Jemperli', or dostarlimab, in combination with standard-of-care chemotherapy - carboplatin and paclitaxel - for all adult patients with primary advanced or recurrent endometrial cancer.

The EMA's Committee for Medicinal Products for Human Use would now begin a formal review process, with a decision expected in the first half of 2025.

Currently, Jemperli in combination with carboplatin and paclitaxel was approved in the EU for treating adult patients with primary advanced or recurrent endometrial cancer that was mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).

The new application was seeking to expand that to include all patients with primary advanced or recurrent endometrial cancer, regardless of their biomarker status.

That, GSK said, would include patients with mismatch repair proficient (MMRp) and microsatellite stable (MSS) tumours, for whom there were currently no approved frontline immunotherapy-based treatments in the EU.

The application was supported by results from part one of the 'RUBY' phase three trial, which met its primary endpoints of progression-free survival (PFS) and overall survival (OS).

At 0836 BST, shares in GSK were up 0.56% at 1,608p.

Reporting by Josh White for Sharecast.com.