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FDA OKs third Lenvima indication

Eisai and Merck have received the Food and Drug Administration’s blessing for its kinase inhibitor Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma, or HCC.

Lenvima was first approved in February 2015 for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. In May 2016, the drug was approved in combination with everolimus for patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy.

This new approval was based on results from REFLECT (Study 304), where Lenvima demonstrated a proven treatment effect on overall survival  by statistical confirmation of non-inferiority, as well as statistically significant superiority and clinically meaningful improvements in progression-free survival and objective response rate when compared with sorafenib in patients with previously untreated unresectable HCC.

"Unresectable hepatocellular carcinoma is an extremely difficult-to-treat cancer, with no new first-line systemic therapy options for more than a decade," Memorial Sloan Kettering Cancer Center medical oncologist Ghassan Abou-Alfa said in a press statement. "Reflect is the first-ever positive Phase 3 trial against an active comparator in unresectable HCC. The efficacy and safety data from Reflect are important findings for oncologists and others in the multidisciplinary teams who treat liver cancer, as well as for our patients who are affected by it."

"Eisai strives to be a leading global R&D-based pharmaceutical company, driven by our human healthcare mission to improve the lives of patients and their loved ones," said Shaji Procida, Eisai president, chief operating officer and commercial head of the oncology business group of the Americas, in a press statement. "That purpose is what has propelled us toward this win for patients with unresectable hepatocellular carcinoma. Our goal is to bring monumental solutions to patients and healthcare providers, changing expectations for the oncology landscape, and we look forward to continuing this work in our ongoing collaboration with Merck."

"We are pleased by the FDA approval of Lenvima as it marks an important advancement in the treatment of unresectable hepatocellular carcinoma," said Roy Baynes, senior vice president and head of global clinical development, chief medical officer at Merck Research Laboratories, in a statement. "With our shared mission to find solutions for difficult-to-treat cancers, we look forward to working with Eisai to help bring this needed option to patients and physicians."
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