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Eisai gets green light for Lenvima in kidney cancer

New drug awarded breakthrough and priority review status by FDA in RCC


Eisai has bagged a second US approval for its new cancer therapy Lenvima after the FDA gave it the okay to treat advanced renal cell carcinoma (RCC).

Lenvima (lenvatinib mesylate) was launched for differentiated thyroid cancer in the US, the EU and Japan last year, and has been used to treat 900 people to date, bringing in 1.3bn yen (around $12m) in the first quarter of 2016. 

The new orally-active drug is a multiple receptor tyrosine kinase (RTK) inhibitor with broad activity against several VEGF and FGF subtypes and factors involved in cancer cell proliferation. It was awarded breakthrough and priority review status by the FDA in RCC.

It has been approved to treat RCC in combination with Novartis' mTOR inhibitor Afinitor (everolimus) in people who have previously been treated with at least one VEGF-targeted therapy, such as Novartis' Votrient (pazopanib), Bayer/Onyx Nexavar (sorafenib), Pfizer's Sutent (sunitinib) or Roche's Avastin (bevacizumab). 

In trials, the combination was shown to extend progression-free survival (PFS) in this patient population by nine months compared to Afinitor alone. The objective response rate was 37%, versus 6% in the control group.

RCC kills more than 100,000 people worldwide each year and is associated with a five-year survival rate of around 12%. While most first-line therapies such as anti-VEGF drugs provide a short-term benefit they eventually lose their efficacy.

Analysts have suggested that the drug could eventually grow to become a $1bn-plus product, and approval in RCC - the most common form of kidney cancer - is a step forward on that path. 

The drug has been described as the "jewel in the crown" of Eisai's oncology portfolio, according to Eisai Inc chief executive Ivan Cheung. 

The company has been steadily building its cancer portfolio since it bought MGI Pharma in 2007, as it looks for new growth products since it lost patent protection for former blockbusters such as Aricept (donepezil) for Alzheimer's disease and Aciphex (rabeprazole) for acid reflux disease.

Lenvima is also in phase III trials for liver cancer (hepatocellular carcinoma) - with a filing due before the end of the year - and is in phase II for endometrial cancer, melanoma and non-small cell lung cancer (NSCLC).

Eisai recently announced it would test the drug in combination with Merck & Co's checkpoint inhibitor Keytruda (pembrolizumab) in a phase I/II study involving patients with various solid tumours.

Earlier this month, Eisai won EU approval for its Halaven (eribulin mesylate) product as a second-line treatment for adults with inoperable advanced liposarcoma, its second indication after metastatic breast cancer.

Article by
Phil Taylor

16th May 2016

From: Regulatory



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