GSK’s Votrient gains new licence
pharmafile | August 8, 2012 | News story | Sales and Marketing | GSK, NICE, Votrient, soft cell sarcoma
GlaxoSmithKline has gained a new European licence for its cancer pill Votrient adding to its renal cell carcinoma licence.
The European Commission has granted Votrient (pazopanib) a new licence to treat patients with advanced soft tissue sarcoma (aSTS), who have received prior chemotherapy or have progressed within 12 months after adjuvant therapy.
But the drug’s efficacy and safety has only been established in certain STS tumour subtypes, and the licence only extends to a small patient population.
GSK also won a similarly restricted licence for aSTS in the US in April. Its American label also stresses that Votrient has not been shown to be effective in patients with adipocytic STS or gastrointestinal stromal tumours, and so cannot be used in this setting.
Soft tissue sarcomas are a group of cancers that originate in the mesenchymal cells, which are associated with fat, muscle, nerve, blood vessels and other connective tissues.
The European approval is based on a Phase III PALETTE trial, which GSK and the European Organisation for Research and Treatment of Cancer collaborated on.
Dr Paolo Paoletti, president of GSK Oncology, said: “The approval of Votrient for this diverse group of tumours marks progress for patients who have seen few new treatment options in decades.
“GSK is very pleased that our collaborative effort with the European Organisation for Research and Treatment of Cancer allowed us to address the research challenges, thus enabling us to bring a new treatment option to European patients.”
The American Cancer Society says there were just 11,000 patients with STS in the US last year, and fewer of those were advanced cases.
Despite this, it is a therapy area in which pharma companies are interested: for example, PharmaMar’s Yondelis (trabectedin) is recommended by the UK’s NICE as a possible treatment for people with advanced STS.
And in February, Merck KGaA signed a $25 million agreement with Threshold Pharmaceuticals to develop the small molecule drug TH-302, which is in a Phase III study with Johnson & Johnson’s Doxil (doxorubicin), versus Doxil alone in STS patients.
Lilly is also looking at STS as part of a wider clinical development programme for its cancer drug tasisulam.
UK access
In England, Votrient will not be subject to a NICE Single Technology Appraisal due to the small patient population. Funding will be considered at a local level and could include applications from the Cancer Drugs Fund, according to GSK.
Reviews by the reimbursement bodies in Scotland and Wales are planned to take place during the second half of 2012.
Ben Adams
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