KENILWORTH, N.J.-(BUSINESS WIRE)- Merck, branded as MSD outside the United States and Canada, today announced that for the following additional uses in Japan, KEYTRUDA, Merck’s anti-PD-1 medication, received new approvals from the Japan Pharmaceutical and Medical Devices Agency for advanced renal cell carcinoma and head and neck cancer: KEYTRUDA in combination with Inlyta for first-line treatment. And distant metastatic cancer of the head and neck; and KEYTRUDA monotherapy for the first-line treatment of patients with chronic and central metastatic head and neck cancer.
“Today’s approval of three new first-line KEYTRUDA regimens is a significant milestone for patients diagnosed with these advanced forms of cancer and will provide substantial solutions to conventional treatments for patients in Japan.” KEYTRUDA approval in conjunction with axitinib for profoundly unresectable or metastatic RCC is focused on KEYNOTE-426 test results;
Where KEYTRUDA showed statistically significant increases in the dual primary endpoints of overall survival and progression-free survival associated with sunitinib monotherapy in combination with axitinib.
The KEYTRUDA first-line treatment clearance for patients with chronic or remote metastatic head and neck cancer is based on the results of Phase 3 KEYNOTE-048 trial assessing KEYTRUDA in conjunction with platinum and5-fluorouracil or KEYTRUDA monotherapy in contrast with standard treatment as first-line treatment in patients with recurrent or metastatic head and neck squamous
“Recent KEYTRUDA approvals for advanced renal cell carcinoma and head and neck cancer draw on existing approvals for melanoma, advanced non-small cell lung cancer, and advanced MSI-H cancers, allowing us to introduce KEYTRUDA to even more patients in Japan.” Renal cell carcinoma is by far the most common type of kidney cancer, with around 403,000 cases of kidney cancer being diagnosed annually in Japan.
KEYTRUDA ® Injection KEYTRUDA is an anti-PD-1 treatment that acts by stimulating the immune system of the body to help detect and kill tumor cells. Currently there are more than 1,000 reports of KEYTRUDA across a wide range of tumors and clinical environments.
The KEYTRUDA clinical trial strives to clarify KEYTRUDA’s function through cancers and the variables that can determine the probability of a patient benefiting from KEYTRUDA therapy, including investigating many specific biomarkers.