Having Previously Won US Approvals, Pembrolizumab Has Now Cleared The EU, For Two Kinds Of Advanced Gynecological Cancers... [Immaterial News]

This is good news, but quite a few patients were already enrolled in the studies that won the earlier FDA approvals, so it will mean only marginal growth in revenue, for Merck -- but still very good stuff.

Most of all for women whose gynecological cancers have progressed, this offers some hope. Here is the Merck press release:

. . .[T]he European Commission has approved two new indications for KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in gynecologic cancers. The first approval is for KEYTRUDA, in combination with carboplatin and paclitaxel, for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy. The second approval is for KEYTRUDA, in combination with chemoradiotherapy (CRT), for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy. With these decisions, KEYTRUDA is now approved for 30 indications in the EU, including five in gynecologic cancers – three in endometrial cancer and two in 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. . . .”

In January 2024, KEYTRUDA in combination with CRT was approved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer based on PFS results from the KEYNOTE-A18 trial. The KEYTRUDA regimen reduced the risk of disease progression or death by 41% (HR=0.59 [95% CI, 0.43-0.82]) versus concurrent CRT alone for these patients. . . .

Both of these populations for treatment cleared the US FDA earlier in the year. Now you know. Onward, smiling -- voting tomorrow. Go Buffs!

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