European Commission grants marketing authorisation for pazopanib (Votrient®)

GlaxoSmithKline plc announced today that the European Commission has granted pazopanib marketing authorisation for the treatment of patients with advanced soft tissue sarcoma (aSTS) who have received prior chemotherapy or have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes.

“The approval of Votrient for this diverse group of tumours marks progress for patients who have seen few new treatment options in decades,” said Dr. Paolo Paoletti, President, GSK Oncology. “GSK is very pleased that our collaborative effort with the European Organization for Research and Treatment of Cancer (EORTC) allowed us to address the research challenges thus enabling us to bring a new treatment option to European patients.”

About soft tissue sarcoma

Soft tissue sarcomas constitute a group of rare cancers arising from mesenchymal cells. These cells normally give rise to soft tissues including fat, muscle, nerve, blood vessels and other connective tissues. In Europe, it is estimated that soft tissue sarcoma (STS) represents an average of 5 out of 100,000 new cancer diagnoses a year. [1] The population of patients who are eligible for treatment with Votrient would be smaller than these figures because pazopanib is licensed only for patients with advanced soft tissue sarcoma, and because of the other limitations on the approved indication.

About Votrient® (pazopanib)

In the European Union (EU), Votrient is now approved for use in adult patients with subtypes of advanced Soft Tissue Sarcoma who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes.

Votrient is also approved in the EU as first line treatment of advanced Renal Cell Carcinoma (RCC) in adults, including those who have received prior cytokine therapy for advanced disease.

The most important serious adverse reactions identified in the RCC or STS trials were transient ischaemic attack, ischaemic stroke, myocardial ischaemia, myocardial and cerebral infarction, cardiac dysfunction, gastrointestinal perforation and fistula, QT prolongation and pulmonary, gastrointestinal and cerebral haemorrhage, reversible posterior leukoencephalopathy syndrome, all adverse reactions being reported in < 1 % of treated patients. Other important serious adverse reactions identified in STS trials included venous thromboembolic events, left ventricular dysfunction and pneumothorax.

Fatal events that were considered possibly related to pazopanib included gastrointestinal haemorrhage, pulmonary haemorrhage/haemoptysis, abnormal hepatic function, intestinal perforation and ischemic stroke.

The most common adverse reactions (experienced by at least 10 % of the patients) of any grade in the RCC and STS trials included: diarrhoea, hair colour change, skin hypopigmentation, exfoliative rash, hypertension, nausea, headache, fatigue, anorexia, vomiting, dysgeusia, stomatitis, weight decreased, pain, elevated alanine aminotransferase and elevated aspartate aminotransferase.

Detailed information on the use of Votrient and its safety profile are described in the Summary of Product Characteristics, which will be published on the EMA website, together with the European Public Assessment Report (EPAR, http://www.ema.europa.eu) and in the Community Register of Medicinal Products on the European Commission’s website (http://ec.europa.eu/health/documents/community-register/html/index_en.htm).

References

1. P. G. Casali,J.-Y. Blay and On behalf of the ESMO/CONTICANET/EUROBONET Consensus Panel of experts Soft tissue sarcomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up, Annals of Oncology (2010) 21 (suppl 5): v198-v203.