FDA gives green light for Keytruda plus Lenvima combination
Merck and Eisai have received the Food and Drug Administration’s blessing for the combination of Keytruda, Merck’s anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the first-line treatment of adult patients with advanced renal cell carcinoma.
“This approval is based in part on data demonstrating that Keytruda plus Lenvima significantly reduced the risk of disease progression or death versus sunitinib,” said Dr. Robert Motzer, Jack and Dorothy Byrne chair in Clinical Oncology, Kidney Cancer Section Head, Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center. “This is a significant milestone for newly diagnosed patients with advanced renal cell carcinoma and introduces a promising combination option in the first-line setting.”
“This FDA approval reinforces the potential of Keytruda plus Lenvima, which is now approved for two different types of cancer. In the study, Keytruda plus Lenvima demonstrated a survival benefit for patients with advanced renal cell carcinoma, supporting the importance of this combination as a new first-line treatment option for these patients,” said Dr. Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories. “At Merck, we are focused on delivering meaningful innovations that extend the lives of people with cancer. We are proud to see how our collaboration with Eisai can now help to improve survival outcomes for patients with advanced renal cell carcinoma and are committed to further exploring Keytruda plus Lenvima in other difficult-to-treat cancers.”
“This FDA approval is truly significant for the advanced renal cell carcinoma community. The CLEAR/KEYNOTE-581 trial shows treatment with Keytruda A plus Lenvima resulted in superior outcomes across progression-free survival, overall survival and objective response rate versus sunitinib in patients with advanced renal cell carcinoma,” said Dr. Takashi Owa, chief medicine creation and chief discovery officer, Oncology Business Group at Eisai. “This milestone is a testament to our dedication to developing new therapeutic options for people living with advanced cancers, which is fueled by our passion for aiming to improve cancer care for patients, and amplified by the teamwork resulting from our collaboration with Merck.”