FDA granted full approval to Keytruda for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
The phase III NRG-GY018 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel) met its primary endpoint of progression-free survival for the treatment of patients with stage 3-4 or recurrent endometrial carcinoma regardless of mismatch repair status.
Merck will stop the phase III KEYNOTE-991 trial investigating Keytruda (pembrlizumab), Merck’s anti-PD-1 therapy, in combination with Xtandi (enzalutamide) and androgen deprivation therapy for the treatment of patients with metastatic, hormone-sensitive prostate cancer.
FDA approved Keytruda (pembrolizumab) for adjuvant treatment following resection and platinum-based chemotherapy for stage 1B, 2, or 3A non-small cell lung cancer.
FDA accepted, for priority review, supplemental Biologics License Applications for Padcev (enfortumab vedotin-ejfv) and Keytruda (pembrolizumab) for use of these two agents in combination for the treatment of patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy.
Topline results from the pivotal phase III KEYNOTE-859 trial investigating Keytruda (pembrolizumab), in combination with chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, were positive.
Patients with high-risk stage III-IV melanoma who received Keytruda (pembrolizumab) after surgery reported a better quality of life than patients who received the previous standard-of-care treatment with either ipilimumab or high-dose interferon, according to a large clinical trial led by the SWOG Cancer Research Network.
Merck, known as MSD outside of the United States and Canada, today announced that Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, received four new approvals from Japan’s Ministry of Health, Labor and Welfare. The indications included TNBC, renal cell carcinoma, cervical cancer, and melanoma.
FDA granted Fast Track designation to PDS0101 in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.
In a three-day meeting this week, the FDA Oncologic Drugs Advisory Committee will be asked to determine viability of six indications for drugs that target PD-/PD-L1 proteins.
