Merck's KEYTRUDA Gains European Approval for Two New Gynecologic Cancer Treatments
With these approvals, KEYTRUDA is now authorized for 30 indications in the EU, including five in gynecologic cancers, Merck said in a statement.
RAHWAY: Merck, also known as MSD outside the US and Canada, announced that the European Commission (EC) has approved two new indications for KEYTRUDA (pembrolizumab), its anti-PD-1 therapy, in gynecologic cancers.
The first approval is for use with carboplatin and paclitaxel as a first-line treatment for adults with primary advanced or recurrent endometrial carcinoma who are eligible for systemic therapy. The second approval is for KEYTRUDA combined with chemoradiotherapy (CRT) for adults with FIGO 2014 Stage III-IVA locally advanced cervical cancer who have not undergone prior definitive therapy.
With these approvals, KEYTRUDA is now authorized for 30 indications in the EU, including five in gynecologic cancers—three for endometrial cancer and two for cervical cancer.
“These KEYTRUDA-based regimens have the potential to change the treatment paradigm for people with endometrial and cervical cancer, two of the most commonly diagnosed cancers among women in Europe,” said Dr Gursel Aktan, vice president, global clinical development, Merck Research Laboratories.
“These approvals underscore the continued expansion of the use of KEYTRUDA in diverse patient populations and treatment settings with utility of KEYTRUDA ranging from earlier lines of therapy to treating advanced disease” the company stated.
