European Commission grants marketing authorisation for Pazopanib (Votrient®) in the treatment of certain advanced soft tissue sarcoma subtypes
GlaxoSmithKline (GSK) announced on the 7th of August 2012 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 Pazopanib 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.”
In the European Union (EU), Pazopanib 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. Pazopanib 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.
Votrient® is a medicine that contains the active substance Pazopanib. It is available as oral medicine = tablets (200 mg; 400 mg). The active substance in Votrient®, Pazopanib, is a protein kinase inhibitor. This means that it blocks some specific enzymes known as protein kinases. These enzymes can be found in some receptors on the surface of cells that are involved in the growth and spread of cancer cells, such as ‘VEGFR’, ‘PDGFR’ and ‘KIT’. By blocking these enzymes, Pazopanib can reduce the growth and spread of the cancer.
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.
Important for patient advocacy groups and patients: Detailed information on the use of Pazopanib 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).
Currently only the information about Pazopanib in Advanced Renal Cell Carcinoma (RCC) (= a type of Kidney Cancer) is available on EMA website – but in many different languages.