BRIEF—Japanese approval for three first-line Keytruda regimens

21 December 2019

US pharma giant Merck, known as MSD outside the USA and Canada, yesterday announced that Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, received new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA) in advanced renal cell carcinoma (RCC) and head and neck cancer for the following additional indications in Japan:

Keytruda in combination with Inlyta (axitinib) for the first-line treatment of patients with radically unresectable or metastatic RCC;
Keytruda in combination with chemotherapy for the first-line treatment of patients with recurrent or distant metastatic head and neck cancer; and
Keytruda monotherapy for the first-line treatment of patients with recurrent or distant metastatic head and neck cancer.

“Advanced renal cell carcinoma and head and neck cancer have historically been associated with poor outcomes and new treatment options are needed in Japan,” said Dr Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories.

“Today’s approval of three new first-line Keytruda regimens represent a significant milestone for patients diagnosed with these aggressive forms of cancer and will provide patients in Japan with important alternatives to standard therapies,” he added.