Shares in UK drug giant GlaxoSmithKline were on the rise this morning after it emerged that its new cancer drug Votrient has been cleared by US regulators, marking its first approval worldwide.
The green light by the US Food and Drug Administration was widely expected given that its Oncologic Drugs Advisory Committee voiced unanimous support for the drug earlier this month after concluding that its benefit-to-risk profile was favourable for patients with advanced renal cell carcinoma, a disease that kills around 13,000 a year in the US alone.
Votrient (pazopanib) is a once-daily, oral angiogenesis inhibitor capable of slowing down disease progression in patients with advanced kidney cancer by cutting off blood supply to the tumour and thereby starving it of essential oxygen and other nutrients necessary for its growth.
Approval was based on a Phase III clinical trial showing that GSK’s drug reduced the risk of tumour progression or death by 54% compared to placebo, regardless of prior treatment. Specifically, the study showed that patients given Votrient experienced an overall median progression-free survival of 9.2 months versus 4.2 months with placebo.
Importantly, the trial also showed that the drug was generally well tolerated and that patients did not experience a decline in health-related quality of life, with no significant differences observed between the Votrient and placebo treatment arms, the company said.
New option
Commenting on its approval, Paolo Paoletti, Senior Vice President of GSK’s Oncology R&D Unit, said: “While treatment has improved in the past few years with the introduction of targeted therapies, advanced RCC remains a challenging disease”, and Votrient “will join existing targeted therapies to provide physicians with a new oral treatment option to their patients with advanced renal cell cancer”.
The drug’s approval is also good news for GSK because it announced back in 2007 that, in line with its strategy of being an oncology powerhouse, it would launch five new cancer drugs by 2010, Votrient being one of them. Progress has, however, been mixed with regard to the other chosen four – while the cervical cancer vaccine Cervarix and Promacta (eltrombopag) for thrombocytopenic purpura have already made it to market, the firm has pulled all its marketing applications for the anti-emetic Rezonic (casopitant) and US regulators are still reviewing HuMax-CD20 (ofatumumab) for leukaemia.
Votrient, the potential of which is also currently being assessed for various other cancer types, was filed for approval in RCC with European regulators earlier this year.
