The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of MSD’s KEYTRUDA for two gynaecological cancer indications.
The first positive opinion supports the use of KEYTRUDA along with carboplatin and paclitaxel, followed by the treatment alone, as a first-line therapy option for adults with primary advanced or recurrent endometrial carcinoma. These patients should be candidates for systemic therapy.
This recommendation is based on the KEYNOTE-868 trial, which showed significant improvement in progression-free survival with the KEYTRUDA-based regimen compared to placebo.
The second opinion recommends granting approval for KEYTRUDA plus chemoradiotherapy (CRT) to treat International Federation of Gynecology and Obstetrics (FIGO) 2014 Stage III-IVA locally advanced cervical cancer in adult patients who did not receive definitive therapy previously.
This recommendation is based on the KEYNOTE-A18 trial, which demonstrated significant improvements in overall survival and progression-free survival when KEYTRUDA was combined with concurrent CRT.
The European Commission will now review CHMP’s recommendations for marketing authorisation in the European Union (EU) with final decisions anticipated in the fourth quarter of 2024.
These would be the third and second indications for KEYTRUDA in endometrial and cervical cancers, respectively, in Europe.
Merck Research Laboratories global clinical development vice-president Dr Gursel Aktan stated: “At Merck, we are deeply committed to expanding the role of KEYTRUDA to improve outcomes for more patients facing difficult-to-treat gynaecologic cancers as we work to address the impact of women’s cancers around the world.
“These positive CHMP opinions bring us one step closer to providing new immunotherapy-based regimens to more patients with endometrial and cervical cancer in the European Union who may benefit. We look forward to the European Commission’s decisions.”
