GSK: EU's CHMP Recommends Approval Of Jemperli Plus Chemotherapy In Certain Endometrial Cancer

(RTTNews) - Biopharma major GSK plc (GSK, GSK.L) announced Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion recommending approval of Jemperli (dostarlimab) in combination with carboplatin-paclitaxel (chemotherapy).

The recommendation is for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.

The company expects the decision on European Union marketing authorisation by the end of the year.

If approved, dostarlimab plus chemotherapy will be a new frontline treatment option in the EU for dMMR/MSI-H primary advanced or recurrent endometrial cancer.

GSK's application for the authorisation of dostarlimab is based on interim analysis results from Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial.

Part 1 of the RUBY trial met its primary endpoint of investigator-assessed progression-free survival or PFS in patients treated with dostarlimab plus carboplatin and paclitaxel in the dMMR/MSI-H population.

The company noted that the safety and tolerability profile for dostarlimab plus carboplatin and paclitaxel was generally consistent with the known safety profiles of the individual agents.

The opinion follows the July 2023 expansion of the label for Jemperli in the US to include this indication.

Jemperli was also approved in the United Kingdom earlier this month in combination with platinum-containing chemotherapy for the treatment of adult patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.

The application remains under review in Australia, Canada, Switzerland and Singapore.

In the EU, Jemperli currently has conditional approval as a monotherapy to treat adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.

Once the European Commission approves the frontline indication for Jemperli + chemotherapy, this conditional approval would be converted to full approval at the same time. A decision is expected by the end of this year.

Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement. The collaboration has resulted in three monospecific antibody therapies that have progressed into the clinic. GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of each of these medicines under the agreement.

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