GSK’s Jemperli secures European approval for advanced endometrial cancer treatment

UNITED KINGDOM — GlaxoSmithKline (GSK) has achieved a significant milestone as the European Commission granted marketing authorization for ‘Jemperli,’ also known as dostarlimab.

This approval is for its use in combination with chemotherapy for a specific segment of patients dealing with advanced or recurrent endometrial cancer.

The authorization targets adult patients diagnosed with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer, who are deemed suitable candidates for systemic therapy.

Endometrial cancer, distinct from endometriosis, primarily affects postmenopausal women, originating in the inner lining of the uterus (endometrium).

GSK estimates that approximately 417,000 women globally are diagnosed with endometrial cancer each year, and the rates are projected to rise by nearly 40% between 2020 and 2040.

By combining Jemperli with carboplatin-paclitaxel, GSK aims to equip healthcare professionals with an effective tool to address the specific needs of this patient population.

Notably, the marketing authorization builds upon the conditional approval Jemperli had previously received as a monotherapy for adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer.

This approval has now been converted to full approval, signifying the expanded scope of its application.

Hesham Abdullah, Senior Vice President and Global Head of Oncology Research and Development at GSK, highlighted the challenges faced by patients with this form of endometrial cancer, emphasizing disease progression and poor long-term outcomes with current standard treatments.

He expressed pride in the recent approvals for Jemperli, believing it transforms the landscape of frontline endometrial cancer treatment and holds promise as a foundational immuno-oncology therapy.

In the United States, Jemperli is indicated in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for adults with primary advanced or recurrent endometrial cancer that is dMMR.

Additionally, it is approved as a single agent for adults with dMMR recurrent or advanced endometrial cancer that has progressed following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

The supplemental Biologics License Application (sBLA) supporting the new indication in combination with carboplatin and paclitaxel received Breakthrough Therapy designation (BTD) from the FDA, highlighting the potential significance of this treatment approach.

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