Afinitor approved in EU
pharmafile | August 6, 2009 | News story | Research and Development, Sales and Marketing |Â Â Afinitor, Cancer, Europe, NovartisÂ
Novartis’ new kidney cancer drug Afinitor (everolimus) has been approved in the EU for use when products such as Sutent and Nexavar fail to halt the disease.
Nearly 40% of all renal cell carcinoma (RCC) patients have advanced cancer at time of diagnosis, meaning that their tumours have spread beyond the kidneys. New targeted drugs like Pfizer’s Sutent, Bayer Schering’s Nexavar are increasingly being used as first-line treatment, but until now there have been few options for patients whose disease failed to respond to these products.
“This approval means that across Europe thousands of patients with advanced kidney cancer now have the opportunity for a clear treatment path with Afinitor if their disease progresses after treatment with a targeted therapy,” said David Epstein, president and chief executive of Novartis Oncology and Novartis Molecular Diagnostics.
The drug is in the same m-Tor class of treatments as Wyeth’s Torisel (temsirolimus), which gained first-line approval to treat RCC in 2007.
While Afinitor will not be competing with Torisel as a first-line treatment, Novartis hope its easier administration will make it a more attractive option. Torisel is administered parenterally every week, while Afinitor is an oral treatment.
Data from the RECORD-1 trail shows Afinitor (everolimus) more than doubled median time without tumour growth and reduced the risk of disease progression or death by 67% compared with placebo.
In February 2008 an independent data monitoring committee advised trials to be stopped after interim results showed patients receiving Afinitor experienced a significant delay in cancer progression or death compared with patients receiving placebo.
Afinitor is being studied in multiple cancer types, including RCC, neuroendocrine, breast, gastric and hepatocellular carcinoma (HCC), as well as tuberous sclerosis complex (TSC) and non-Hodgkin’s lymphoma.
Novartis are conducting a study of Afinitor in combination with Avastin (bevacizumab), and Afinitor’s use as a first-line treatment for RCC is also being considered.
Afinitor gained US approval in March to treat advanced RCC after failure of treatment with Sutent or Nexavar.
The drug’s active ingredient everolimus was first approved in 2003 as Certican for the prevention of organ rejection in heart and kidney transplant recipients.
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