Health Canada approves Novartis' Afinitor to treat patients with mRCC

Novartis Pharmaceuticals Canada Inc. (Novartis) announced today that Afinitor(R) (everolimus), a once-daily oral cancer treatment, has been approved by Health Canada for patients with metastatic renal cell carcinoma (mRCC), also known as advanced kidney cancer, after failure of initial treatment with VEGF-receptor targeted therapies Sutent(R) (sunitinib) or Nexavar(R) (sorafenib). Afinitor(R) represents the first proven treatment option for patients whose cancer progressed despite prior targeted therapy with Sutent(R) or Nexavar(R).

"We have seen tremendous developments in the treatment of kidney cancer, as new targeted therapies are helping patients manage a difficult-to-treat disease that is often diagnosed at advanced stages. But for patients with advanced disease who have failed on initial therapies, access to new treatment options is urgently needed," said Deborah Maskens, Vice-Chair, Kidney Cancer Canada. "Afinitor is an important new option for sequential treatment, and brings new hope to Canadians living with kidney cancer."

Prior to Afinitor, no other therapy has been studied in a Phase III trial in this patient population where there is an important unmet medical need. Sutent and Nexavar are commonly used as initial treatments for metastatic RCC.

The approval is based on data that showed Afinitor, when compared with placebo, more than doubled the time without tumour growth or death in patients with metastatic renal cell carcinoma (4.9 vs. 1.9 months) and reduced the risk of disease progression or death by 67% (hazard>

"With nearly 40 per cent of renal cell carcinoma patients diagnosed at an advanced stage, new treatment options like Afinitor are essential to help these patients battle their disease," said Dr. Sebastien Hotte, Medical Oncologist, Juravinski Cancer Centre, and contributing investigator of the RECORD-1 trial, the basis for Health Canada's approval of Afinitor. "Prior to this approval, patients with metastatic renal cell carcinoma had limited options once they experienced tumour progression after VEGF-receptor targeted therapy. Based on clinical trial data, Afinitor should be considered standard therapy when VEGF-receptor targeted therapy fails."

Afinitor inhibits mTOR, a protein in the cancer cell that controls tumour cell division and blood vessel growth. Preclinical and clinical data have established the important role of mTOR in the development and progression of several types of tumours.