GlaxoSmithKline’s Votrient is one step closer to approval in the US after an FDA advisory committee voiced unanimous support for the drug as a treatment for kidney cancer.
The UK drugmaker said that, specifically, the US Food and Drug Administration’s Oncologic Drugs Advisory
Committee has concluded that the benefit-to-risk profile of Votrient (pazopanib) is acceptable for patients with advanced renal cell carcinoma, the most common type of kidney cancer which claims around 13,000 lives a year in the US.
The drug is a once-daily angiogenesis inhibitor designed to
prevent the growth of new blood vessels to tumours, thereby starving the cancer of vital nutrients and oxygen, and has shown promise with its ability to slow down disease progression in Phase III clinical trials.
Data presented earlier this year at the American Society for Clinical Oncology
meeting in Orlando showed the median progression free survival (PFS) for patients taking Votrient was 9.2 months compared with 4.2 months for those on placebo.
In addition, it was revealed that patients with no prior drug treatment experienced 11.1 months of PFS with the drug compared to 2.8
months with placebo, while those who had been taking a cytokine-based treatment showed 7.4 months versus 4.2 months with placebo.
Votrient has not yet received a regulatory green light in any country, but a marketing request was also filed with the European Medicines Agency in March this yea
r.
Government orders and promising trial results
Meanwhile, in further good news for the firm, GSK confirmed this morning that it has received additional orders for its H1N1 2009 pandemic flu vaccine, with a further 22 contracts for 149 million doses of the vaccine, bringing the total number of doses ordered to 440 million.
The company says it has started shipping first supplies of the vaccine to governments this week.
Elsewhere, GSK and its US partner Xenport reported positive results from a Phase II trial of GSK1838262/XP13512 (gabapentin enacarbil) in adult patients with neuropathic pain associated with post-herpetic neuralgia (PHN) following an attack of shingles.
The double-blind, two-period cross-over study with patients who had not responded well to previous treatment with gabapentin met its primary endpoint, showing that 3,600mg/day of GSK 1838262 demonstrated a statistically significant improvement over 1,200mg/day in reducing pain.
