The positive opinion is for Sutent (sunitinib malate) in metastatic renal cell carcinoma (mRCC) after failure of interferon alpha or interleukin-2-based therapy. The positive opinion was also granted for gastrointestinal stromal tumor (GIST), a rare stomach and intestinal cancer, in patients who are resistant or intolerant to imatinib mesylate.
The recommended approval is for conditional marketing authorization, which means additional data will be submitted to confirm the risk-benefit of Sutent for mRCC patients. This is the first time the Committee for Human Medicinal Products (CHMP) has used the new directive intended for drugs for patients with an unmet medical need.
Developed by Pfizer, Sutent is an oral therapy belonging to a new class of multi-kinase inhibitors that attack cancer by inhibiting both tumor growth and blood supply.
The primary treatment option for newly diagnosed GIST and mRCC patients is surgery. GIST patients with advanced disease after surgery are treated with imatinib mesylate, where patients with mRCC are generally treated with cytokines. For patients with advanced cancers following these treatments, there are currently few treatment options.
The FDA approved Sutent in January 2006 for the treatment of advanced RCC as well as GIST in patients whose disease has progressed or who are unable to tolerate treatment with imatinib mesylate. Sutent’s US approval was the first time that the FDA approved a new cancer medicine for two indications simultaneously.