Pfizer’s Sutent receives conditional EMEA approval
pharmafile | August 3, 2006 | News story | Sales and Marketing |Â Â Â
Pfizer's new kidney cancer drug Sutent is rapidly catching up with its recently approved rival, Bayer's Nexavar.
Sutent (sunitinib) has been conditionally approved in Europe for advanced and/or metastatic renal cell carcinoma (mRCC) when standard treatments have failed.
The EMEA issued a conditional authorisation for Sutent based on two phase II studies and final approval is dependent on its Committee for Human Medical Products giving a satisfactory review to Sutent's phase III studies, which Pfizer is submitting this month.
Medicines can be conditionally approved to treat those diseases which have few available treatments, even when full clinical data is not immediately forthcoming, if they meet unmet medical needs and rapid approval is in the interests of public health.
Last month, Bayer got the go-ahead from European regulators for Nexavar in the treatment of advanced renal cell carcinoma. The FDA had granted it approval in January – when it became the first new treatment for the disease in 10 years.
Pfizer's Sutent is an oral therapy belonging to a new class of multi-targeted drugs that attack cancer by inhibiting both tumour growth and blood supply.
The EMEA also granted Sutent a conditional approval to treat gastrointestinal stromal tumour (GIST) in patients who fail to respond to Novartis Glivec (imatinib) or are intolerant to it.
Pfizers chief medical officer Dr Joseph Feczko said: "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."
The most serious side effects associated with Sutent were pulmonary embolism, thrombocytopenia, tumour haemorrhage, febrile neutropenia and hypertension. Temporary suspension of Sutent has been recommended in patients with severe hypertension that is not controlled with medical management.
Sutent's estimated peak year sales are expected at around $1.2 billion, with Nexavar predicted to at least equal this figure in its own peak year sales.
