NICE has recommend that three separate treatments for thyroid cancer should be made available for use on the NHS: Ipsen’s Cometriq, Bayer’s Nexavar, and Eisai’s Lenvima. The former two were previously only available via the Cancer Drugs Fund (CDF), and Eisai’s finally gains approval after delays of over two years. Eisai’s tyrosine kinase inhibitor was
NICE has stated that Eisai’s breast cancer drug Halaven should not be funded by the NHS, citing uncertainty in the clinical evidence submitted. Eisai already has a strained relationship with NICE which led to two years to review thyroid cancer drug Lenvima due to changes in its procedures, before rejecting it last month. NICE had
Eisai has filed its cancer drug Lenvima (lenvatinib) in Europe for use against advanced or metastatic renal cell carcinoma (RCC), where its review will be fast-tracked.
Eisai have confirmed that they have submitted their anticancer agent, Lenvatinib, with regulatory agencies in both Europe and the US. Specifically, Lenvatinib has been submitted for progressive radioiodine-refractory, differentiated thyroid cancer. The regulatory submissions are based on a 392-patient Phase III clinical trial, which showed the drug achieved a statistically significant improvement in progression-free survival.
Eisai is to suspend commercial distribution of its new epilepsy drug Fycompa in Germany, noting that they continue to disagree with the country’s reimbursement regulatory body’s rejection of the therapy. In March, the German Federal Joint Committee declared that they consider the additional benefit of Fycompa unproven when compared to two other treatments – GlaxoSmithKline’s
Arena Pharmaceuticals and partner Eisai are optimistic that regulators will approve their obesity drug, lorcaserin, after responding to a rejection issued by the US Food and Drug Administration in October 2010. Arena has submitted their response to the comprehensive reply letter from the Food and Drug Administration which cited a number of reasons for their
In final draft guidance given yesterday, the National Institute for Health and Clinical Excellence (NICE) announced that they are not recommending Eisai’s Halaven (eribulin) for the treatment of locally-advanced or metastatic breast cancer in people whose disease has progressed after at least two chemotherapeutic regimens for advanced disease. Although the evidence shown to NICE’s independent