European regulators have given the stamp of approval for GlaxoSmithKline to market its cancer drug Votrient as a treatment for certain types of soft tissue sarcomas, a group of rare cancers arising from mesenchymal cells.
Specifically, the European Commission has issued a green light for the use of Votrient (pazopanib) to treat patients with advanced soft tissue sarcoma (aSTS) who have received prior chemotherapy or have progressed within 12 months after (neo) adjuvant therapy.
Approval was based on data from the 369-patient PALETTE trial, which showed that Votrient enabled patients to live a median of 4.6 months - some 3.1 months longer than placebo - without their disease progressing.
It also showed that 50% of patients experienced some degree of tumour shrinkage compared with 12% of the control group.
In Europe, it is estimated that soft tissue sarcoma (STS) represents an average of 5 out of 100,000 new cancer diagnoses a year, though GSK notes that Votrient's target population would be smaller because of the restrictions on the approved indication.
Nevertheless, "the approval of Votrient for this diverse group of tumours marks progress for patients who have seen few new treatment options in decades,” comments Paolo Paoletti, president, of GSK Oncology.
Votrient, a once-daily, oral angiogenesis inhibitor, was approved in the USA in October 2009 for advanced kidney cancer and got a conditional green light in that indication from the European Medicines Agency in June 2010.
US clearance
The US Food and Drug Administration also approved Votrient for advanced STS back in April, following a positive recommendation by its Oncologic Drugs Advisory Committee in March.
However, panelists did voice concern about the side effects profile of the drug, as 98 of the 296 patients taking Votrient experienced a serious adverse event compared with 29 on placebo, and 47 patients discontinued the treatment due to adverse events, compared with six in the placebo arm.
