The U.K. National Institute for Health and Care Excellence recommended Eisai Co. Ltd.'s Lenvima for treating certain adults with advanced liver cancer.
The drug price watchdog gave the nod to Lenvima, also known as lenvatinib, for patients whose liver is well-functioning but whose disease cannot be treated through surgery. NICE also said the patients receiving Lenvima should be fully active and able to carry on all pre-disease performance without restriction or be able to carry out work of a light or sedentary nature despite being restricted in physically strenuous activity.
NICE's recommendation is also contingent on Eisai providing Lenvima under a commercial arrangement between the drugmaker and the agency.
Lenvima is a kinase inhibitor designed to block certain enzymes that promote cancer growth. The treatment will benefit about 900 patients each year in the U.K. following the NICE recommendation.
Bayer's Nexavar, or sorafenib, is the only first-line treatment available to patients in the U.K., the regulator said in a statement. However, about a fourth of patients stop treatment with the drug because of adverse events, including diarrhea, rashes, weight loss, nausea and vomiting.
Lenvima, which also has hypertension as a side effect, can offer an alternative first-line option for patients, NICE said.
Lenvima is approved in the U.S. and EU as first-line treatment for adults with hepatocellular carcinoma, or liver cancer, that is advanced or cannot be removed through surgery and who have received no prior systemic therapy.
In March, Tokyo's Eisai and Kenilworth, N.J.-based Merck & Co. Inc. agreed to form a partnership to jointly develop and commercialize Lenvima both as a single treatment and in combination with Merck's Keytruda. Eisai will book product sales globally, while the companies will share development and marketing costs equally, as well as gross profits from Lenvima.