Recently, Eisai tumor industrial pipelines harvest great news, Lenvima its anti-cancer drug approved by the FDA for the treatment of advanced renal cell carcinoma (renal cell carcinoma, RCC).
Last year, Lenvima (lenvatinib mesylate) in the Americas, Europe, Japan, for the treatment of differentiated thyroid cancer. So far it has treated about 900 patients in 2016 first quarter sales of 1.3 billion yen (approximately US $ 12 million).
Lenvima (lenvatinib mesylate) is an oral inhibitor of multiple receptor tyrosine kinase, involved in tumor cell proliferation of VEGF, FGF and a variety of cytokines subtypes can produce inhibition. Last July, FDA granted Lenvima breakthrough drugs qualifications in terms of indications of renal cell carcinoma.
The FDA approved Novartis Lenvima mTOR inhibitor Afinitor (everolimus) in combination with, for receiving at least one over-VEGF targeted drug therapy in patients with renal cell carcinoma. VEGF inhibitors include Novartis Votrient (pazopanib), Bayer / Onyx’s Nexavar (sorafenib), Pfizer’s Sutent (sunitinib) and Roche’s Avastin (bevacizumab), etc., are anti-angiogenic therapy.
In clinical trials, compared with Afinitor monotherapy group, Lenvima + Afinitor combination group were progression-free survival was significantly prolonged for nine months. Objective response rate of 37%, while the control group was only 6%.
Renal cell carcinoma is a highly malignant tumor mortality, resulting in approximately 100,000 patients each year die, five-year survival rate is about 12%. While most first-line therapy – such as VRGF inhibitor initially could benefit patients in the short term, but eventually the situation will often appear resistant.
According to the analysis estimated that, Lenvima may eventually become annual sales of more than $ 1 billion blockbuster drugs. Renal cell carcinoma is the most common form of kidney cancer type, so to win renal cell carcinoma indications such Lenvima away from the goal one step closer.
Ivan Cheung, CEO of Eisai’s representation, Lenvima the “crown jewel” Eisai entire tumor industrial pipeline, enough to reflect the drug to Eisai pivotal position. In 2007, Eisai acquired MGI Pharma, began to establish their own cancer drug pipeline. Self-defense material Alzheimer’s drugs Aricept (donepezil) and acid reflux disease medication Aciphex (rabeprazole) after the patent expires, Eisai has been sought can be used as a pillar of the blockbuster.
Lenvima currently in Phase III clinical trials in hepatocellular carcinoma, is expected to submit a listing application this year. In addition, Lenvima also endometrial cancer, melanoma and non-small cell lung cancer and other indications in Phase II clinical trials. Eisai today announced that Merck will work with heavy PD-1 inhibitors Keytruda (pembrolizumab) were associated with the conduct Phase I / II clinical trial in multiple solid tumors.
Lenvima approved, within this month, Eisai tumor industrial pipelines second pile wedding. Not long ago, Eisai’s Halaven (eribulin mesylate) is approved in Europe, as a second-line treatment for adults with advanced soft tissue sarcoma, which is approved for metastatic breast cancer after the second indication.