GlaxoSmithKline’s pazopanib receives position opinion from CHMP

GlaxoSmithKline has announced that its Votrient (pazopanib) drug has been issued with a positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

The product is designed for the treatment of adults with selective subtypes of advanced soft tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease, or those who have progressed within 12 months after (neo) adjuvant therapy.

Although welcoming the committee's decision, GlaxoSmithKline noted that a positive opinion from the CHMP "does not always result in marketing authorisation" for new drugs.

The committee reviewed safety and efficacy data from several clinical trials of pazopanib, including one randomised, multi-centre Phase III study.

GlaxoSmithKline pointed out that efficacy and safety has only been established in certain STS histological tumour subtypes.

Last month, the US Food and Drug Administration approved Votrient for the treatment of patients with certain types of advanced STS who have received prior chemotherapy.