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Merck kidney and uterus cancer treatments granted priority review by FDA

Published on 07/05/21 at 11:23am
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The FDA has granted priority review for Merck (MSD) and Eisai’s application for two new approvals for the combination of Merck’s KEYTRUDA and Eisai’s LENVIMA for the treatment of certain kidney and uterus cancers. 

The applications are for first-line treatment of patients with advanced renal cell carcinoma (RCC), a type of kidney cancer, and the therapy of patients with advanced endometrial carcinoma (a form of uterus cancer) who have disease progression following prior systemic therapy.

The applications come after two Phase III trials. The CLEAR study showed KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in progression free survival (PFS), overall survival (OS) and objective response rate (ORR) versus sunitinib, an already FDA-approved drug for RCC.

The KEYNOTE-775 trial showed KEYTRUDA plus LENVIMA to also demonstrate statistically significant improvements in PFS, OS and ORR, in this instance versus chemotherapy.

These are the first applications to be submitted in the US for this combination therapy based on Phase III clinical data. The FDA has set Prescription Drug User Fee Act (PDUFA) dates, or target action dates, of August 25 and 26 for the advanced RCC applications, and September 3 for the advanced endometrial carcinoma applications.

RCC is by far the most common type of kidney cancer, accounting for about 90% of cases. Worldwide, it is estimated there were more than 431,000 new cases of kidney cancer diagnosed and more than 179,000 deaths from the disease last year. RCC is around twice as common in men as in women.

Endometrial carcinoma begins in the inner lining of the uterus, which is known as the endometrium, and is the most common type of cancer in the uterus. In 2020, it was estimated there were more than 417,000 new cases and more than 97,000 deaths from uterine body cancers worldwide.

Dr Gregory Lubiniecki, Vice President of Oncology Clinical Research at Merck Research Laboratories, said: “Advanced renal cell carcinoma and advanced endometrial carcinoma are aggressive cancers, and patients urgently need new treatment options that may help improve outcomes. 

“We appreciate that the FDA has recognised this significant unmet need and the potential for the combination of KEYTRUDA plus LENVIMA in these patients by granting priority review for these applications.”

Jack Goddard

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