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GSK kidney cancer drug approved in US

Published on 20/10/09 at 11:55am


GlaxoSmithKline's Votrient has been approved in the US by the FDA to treat the most common form of kidney cancer.

This is Votrient's (pazopanib) first approval and the angiogenesis inhibitor has been indicated for advanced renal cell carcinoma (RCC).

The disease, highly resistant to chemotheraphy, kills 13,000 a year in the US and is estimated to account for 85% of all kidney cancers.

The current standard first-line treatment options are Pfizer's Sutent (sunitinib) and Bayer's Nexavar (sorafenib).

In a phase III trial Votrient reduced the risk of tumour progression or death by 54%, regardless of prior treatment.

The overall median progression-free survival was 9.2 months with Votrent and 4.2 months with placebo.

That rose to 11.1 months with treatment-naive patients compared to 2.8 months with placebo.

The advanced RCC market, which makes up a quarter of the RCC patient population as a whole, has become a fierce battleground for pharma manufacturers.

Earlier this year, the FDA approved Novartis' Afinitor (everolimus) for patients who have progressed after treatment with Sutent or Nexavar.

This followed the green lights given to Wyeth's Torisel (temsirolimus) and Roche's Avastin (bevacizumab).

"While treatment has improved in the past few years with the introduction of targeted therapies, advanced RCC remains a challenging disease," says Paolo Paoletti, senior vice president of GSK Oncology's R&D unit.

"Votrient will join existing targeted therapies to provide physicians with a new oral treatment option to their patients with advanced RCC."

The once-daily, oral medication is designed to prevent the growth of new blood vessels and therefore block the growth of kidney cancer tumours.

Like its competitors, Votrient is being tested in a range of clinical trials across other tumour types.

Multiple indications and faster development

Avastin is now approved for five cancers in the US, while Afinitor was recently approved in the EU to treat advanced RCC whose disease progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.

Afinitor also has a European licence under the brand name Certican, for the management of organ transplant rejection, and is in phase III trials against multiple tumour types, including breast and neuroendocrine, as well as tuberous sclerosis complex.

In addition to looking for multiple indications, manufacturers have embraced innovative ways of speeding up the development of cancer drugs.

For example, this summer Merck and AstraZeneca began an unprecedented collaboration on the clinical trials of two early-stage medicines, Merck's MK-2206 and AstraZeneca's AZD6244.

Both drugs target a single kinase pathway - the chemical triggers believed to be vital in cancer growth - but are to be studied as a combination treatment.

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