The Merck and Eisai alliance focuses on the latter’s anti-cancer drugs and is receiving another regulatory approval. FDA has Officially recognized The Eisai drug Lenvima is combined with Merck’s blockbuster Keytruda to treat renal cell carcinoma, the most common type of renal cancer.
The regulatory decision announced on Wednesday night is the third FDA approval of Lenvima since Merck and Eisai began working together in 2018, and the second approval for the combination of Eisai and Keytruda. The pairing of the two drugs combines two different cancer treatments. Eisai’s Lenvima is a tyrosine kinase inhibitor, an anti-cancer drug that blocks enzymes involved in the proliferation of cancer cells. Keytruda is a checkpoint inhibitor that blocks proteins on T cells and prevents them from attacking cancer cells.
Lenvima has been approved for the treatment of patients with advanced renal cell carcinoma who have previously received anti-angiogenesis therapy. This drug prevents the growth of blood vessels that promote cancer growth. The FDA’s latest decision on Lenvima cleared the way for its use as a first-line treatment with Merck’s checkpoint inhibitor.
The new approval of Merck and Eisai is based on the results of a clinical trial comparing the Lenvima/Keytruda drug combination with sunitinib, which is marketed by Pfizer as Sutent. The FDA approved the small molecule for the treatment of kidney cancer, and the drug has become the standard first-line treatment for the disease. In the phase 3 test, the Lenvima/Keytruda combination treatment statistically significantly improved the patient’s survival time without cancer progression, the patient’s overall survival time, and the overall response rate to treatment. In February, the results of the study were presented at the Symposium on Cancer of the Genitourinary System and published in the New England Journal of Medicine.
The most common adverse reactions reported in clinical trials for kidney cancer include fatigue, diarrhea, muscle pain, thyroid hormone deficiency, and oral inflammation and soreness. The safety information on the Keytruda label warns of the risk of immune system-related reactions, which may be serious or fatal, and may occur in any organ or tissue.
Lenvima was first approved by the FDA for the treatment of thyroid cancer in 2015, and then received regulatory approval for advanced renal cell carcinoma the following year. In 2018, the FDA approved Lenvima as a first-line treatment for unresectable liver cancer. Lenvima/Keytruda combination debuts Approved in 2019 for the treatment of endometrial cancer. Last month, the FDA converted the accelerated approval decision to Regular approval.
When Merck and Eisai began to form an alliance in 2018, the two companies agreed to share the development and commercialization of Lenvima as a monotherapy in combination with Keytruda. Merck prepaid US$750 million for its partners and promised to pay an additional US$650 million for certain options. The profits generated by the partnership should be evenly distributed. The agreement also exposes Merck to the obligation to pay Eisai additional payments related to achieving sales and regulatory milestones.
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