GlaxoSmithKline has received approval from the US Food and Drug Administration (FDA) for the Votrient (pazopanib) drug. The drug is approved for the treatment of patients with advanced renal cell carcinoma (RCC), a form of kidney cancer. The FDA’s Oncologic Drugs Advisory Committee (ODAC) had earlier voted unanimously in favor of the drug due to encouraging results from the phase III trial.

The FDA has approved Genentech’s cancer treatment Avastin (bevacizumab) for kidney cancer. Avastin blocks new blood vessels from forming and supplying tumors with the nutrients they need to grow and spread to other parts of the body. This drug is already being used for the treatment of colorectal cancer, breast cancer and non-small cell lung cancer and is being tested for the treatment of more than 30 tumor types.

The US Food and Drug Administration (FDA) has granted priority review to Novartis’ RAD001 (everolimus) on the basis of the drug’s potential to benefit patients suffering from advanced kidney cancer who showed no improvement after the standard treatment. The data collected from a trial shows that RAD001 curbs tumor growth, reducing the risk of disease progression by 70%.Novartis has already applied for marketing authorization for RAD001 with the European Medicines Agency (EMEA) and the Swiss Agency for Therapeutic Products (Swissmedic). EMEA has even accepted the proposed brand name for RAD001, Afinitor®.

Interim results from a major Phase III clinical trial of everolimus (RAD001) showed that the study met its primary endpoint. The interim results indicated that the investigational drug exhibited significantly higher progression-free survival in patients with advanced kidney cancer as compared to placebo. The Phase III clinical trial has been halted and investigators will now offer everolimus to trial subjects who are still taking placebo. Novartis has said that the trial results will be submitted for presentation at the ASCO (American Society of Clinical Oncology) annual meeting in May.

Swiss company Novartis AG has reported that an independent data monitoring committee stopped a major trial of an investigational drug after interim results showed significantly better survival rates in kidney-cancer patients taking the therapy.Novartis was in Phase III of clinical trials, but the independent committee stopped the trial, involving some 400 patients in a dozen countries, because the study met its primary endpoint. Researchers say the targeted therapy could have promise for people with late-stage renal-cell cancer. Researchers are also evaluating the drug’s use in neuroendocrine tumors, lymphoma and other cancers.

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