GSK Receives Positive CHMP Opinion for Jemperli (Dostarlimab) Plus Chemotherapy in dMMR/MSI-H Advanced or Recurrent Endometrial Cancer
GSK
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Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
SmartCom APP learned that biopharmaceutical company GlaxoSmithKline (GSK.US) announced on Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending the approval of Jemperli (dostarlimab) in combination with carboplatin-paclitaxel (chemotherapy).
Recommended for the treatment of adult patients with primary advanced or recurrent endometrial cancer characterized by mismatch repair deficiency (dMMR)/high microsatellite instability (MSI-H), who are candidates for systemic therapy.
The company expects the EU to make a decision on its marketing authorization by the end of this year.
If approved, dostarlimumab in combination with chemotherapy will become a new first-line treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer in the EU.
GlaxoSmithKline PLC.The dostarlimab authorization application is based on the interim analysis results of Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III clinical trial.
The first part of the RUBY trial met its primary endpoint, which was in the dMMR/MSI-H population receivingdostarlimumabProgression-Free Survival (PFS) in patients treated with carboplatin and paclitaxel.
The company pointed out,dostarlimumabThe safety and tolerability of the combination of carboplatin and paclitaxel are generally consistent with the known safety profiles of the individual drugs.
This opinion was put forward following the expansion of Jemperli's label in the U.S. to include this indication in July 2023.
Jemperli was also approved in the UK earlier this month for use in combination with platinum-based chemotherapy for adult patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.
The application is still under review in Australia, Canada, Switzerland, and Singapore.
In the EU, Jemperli has been granted conditional approval as a monotherapy for the treatment of adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer who have progressed during or after prior treatment with a platinum-containing regimen.
Once the European Commission approvesJemperli+ First-line indications for chemotherapy, this conditional approval will simultaneously convert to full approval. A decision is expected to be made by the end of this year.
Jemperli was discovered by AnaptysBio and licensed to TESARO under a collaboration and exclusive license agreement. This collaboration has led to three monospecific antibody therapies entering clinical trials. According to the agreement,GlaxoSmithKline PLC.Will be responsible for the ongoing research, development, commercialization, and production of these drugs.