Lenvima approved for use in kidney cancer

The FDA has granted approval for Eisai’s cancer drug Lenvima in advanced renal cell carcinoma (RCC), good news for the company’s continuing push into the oncology market.

Lenvima (lenvatinib mesylate) was approved and launched for differentiated thyroid cancer in the US, the EU and Japan last year, and earned 1.3bn yen (around $12m) in the first quarter of 2016.

The FDA had granted Lenvima breakthrough therapy designation to Lenvima in RCC, and its approval will help the company’s expansion into the crowded cancer market.

The approval announced late last week is for use against RCC in combination with Novartis’ Afinitor (everolimus) in patients previously treated with at least one VEGF-targeted therapy. Drugs in this category include Novartis’ Votrient (pazopanib), Bayer/Onyx Nexavar (sorafenib), Pfizer’s Sutent (sunitinib) or Roche’s Avastin (bevacizumab).

Analysts forecast that Lenvima could eventually exceed annual sales of $1bn, and the new approval in RCC – the most common form of kidney cancer – will be a major component of that growth.

Eisai’s chief executive of US operations Ivan Cheung has described the drug as the ‘jewel in the crown’ of its oncology portfolio. The oral treatment is a multiple receptor tyrosine kinase (RTK) inhibitor with activity against several VEGF and FGF subtypes and factors involved in cancer cell proliferation.

Phase 3 trial data showed the combination extends 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 patients inevitably see their tumours start to progress again.

The company has been building its cancer portfolio in recent years, having acquired MGI Pharma in 2007 for $3.9 billion, but Lenvima is easily its most competitive oncology product to date.

The Tokyo-headquartered company needs new growth products it’s now post-patent blockbusters Aricept (donepezil) for Alzheimer’s disease and Aciphex (rabeprazole) for acid reflux disease.

Lenvima is also in phase 3 trials for liver cancer (hepatocellular carcinoma) – with a filing due before the end of 2016 – and is in phase 2 for endometrial cancer, melanoma and non-small cell lung cancer (NSCLC).

The company also recently announced a trial combining its drug in combination with Merck’s checkpoint inhibitor Keytruda (pembrolizumab) in a phase I/2 study involving patients with various solid tumours.

Earlier this month, Eisai won EU approval for another of its cancer drugs, Halven (eribulin mesylate) as a second-line treatment for adults with inoperable advanced liposarcoma, building on its first licence in metastatic breast cancer.

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