Drugs Xagena
European Commission has granted Votrient ( 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.
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.
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.
Votrient is also approved in the European Union ( 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 renal cell carcinoma or soft tissue sarcoma 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 less than 1 % of treated patients.
Other important serious adverse reactions identified in soft tissue sarcoma 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 renal cell carcinoma and soft tissue sarcoma 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. ( Xagena )
Source: GlaxoSmithKline, 2012
XagenaMedicine_2012
