Pfizer receives EU approval for Sutent

The European Commission has given Pfizer, the world’s largest pharmaceutical company, marketing authorisation to treat advanced metastatic advanced renal cell carcinoma (mRCC), a type of kidney cancer, with Sutent.

Sutent’s approval means that it can be used in patients who have failed to respond to interferon alpha and interleukin-2 therapies. The drug has also been given conditional marketing approval for the treatment of unresectable and metastatic gastrointestinal tumours (GIST) following the failure of imatinib mesylate treatment.

Pfizer said the authorisation was conditional until it submitted more phase III trial results to the Committee for Human Medicinal Products. Phase II trials for mRCC patients showed that Sutent was successful in achieving a response rate 38 per cent in one study, while in GIST patients, the time until tumour progression after treatment was stretched to 28.9 weeks for Sutent patients, compared to 5.1 weeks with the placebo.

Dr Joseph Feczko, Pfizer’s chief medical officer, remarked: “Patients who had few choices now have a new treatment option for GIST and mRCC.”

“Interim data showed that Sutent prolonged time to tumour progression in clinical study participants with resistant GIST and showed remarkable response rates and response duration across multiple studies in patients with metastatic kidney cancer,” he added.

Pfizer’s oncology sector claims to have more than 200 studies ongoing, as well as two compounds in phase III clinical trials, five in phase II trials and seven in phase I development.

Sutent has the distinction of being the first cancer medicine to be simultaneously approved by the FDA for the treatment of two indications.

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