GlaxoSmithKline (GSK) has been granted a new indication for its fast-growing cancer drug Votrient in the EU, with the European Medicines Agency (EMA) giving the go-ahead for its use in soft tissue sarcoma patients.
Votrient (pazopanib), once-daily oral angiogenesis inhibitor, was first approved in 2009 for treating kidney cancer and is among GSK’s fastest-growing new products, with sales rising 87 per cent to £72m ($112m) in the first half of the year.
One of the main drivers for that increase was approval for the soft tissue sarcoma indication in the US, despite the fact that the cancer is relatively rare. The EU registration will lend additional momentum to the product.
Specifically, Votrient has been cleared for the treatment of adult patients with advanced soft tissue sarcoma who have received prior chemotherapy or have progressed within 12 months of adjuvant therapy.
In Europe, it is estimated that this type of sarcoma represents an average of 5 out of 100,000 new cancer diagnoses a year.
“The approval of Votrient for this diverse group of tumours marks progress for patients who have seen few new treatment options in decades,” commented Dr Paolo Paoletti, president of GSK’s oncology business unit.
Votrient is also benefitting commercially from the failure of Merck & Co/Ariad’s rival sarcoma therapy Taltorvic (ridaforolimus), which was rejected by the FDA earlier this year as maintenance therapy for patients with metastatic soft tissue sarcoma or bone sarcoma.
Analysts polled by Thomson Reuters have forecast global peak sales of around $500m in 2016 for Votrient, with possible upside if the drug proves effective in ongoing studies in other cancers.
GSK has also been testing Votrient for ovarian, breast and non-small cell lung cancer, as well as for age-related macular degeneration.