Pfizer’s Sutent Gains First European Conditional Approval Recommendation
This article was originally published in The Pink Sheet Daily
Executive Summary
The firm may renew sunitinib’s conditional marketing authorization after one year or transition to a full license.
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The European Medicines Agency recommended its first conditional marketing authorization be granted to Pfizer's oncologic Sutent in order to make the oncologic available while gathering additional survival data, the agency said in documents posted May 8. The agency's Committee for Medicinal Products for Human Use (CHMP) recommended April 27 that the European Commission approve Sutent (sunitinib) for treatment of gastrointestinal stromal tumor after failure of imatinib (Novartis' Gleevec ), and for advanced or metastatic refractory renal cell carcinoma. Sutent's FDA approval in January for the same indications was also notable, as it was the first time that FDA simultaneously approved two cancer indications (1 (Also see "Pfizer's Sutent Receives Dual Approvals For Kidney Cancer & Stomach Cancer" - Pink Sheet, 26 Jan, 2006.)). The European Commission outlined the conditional marketing authorization pathway in a regulation in March. The system is designed to bring products that treat an unmet medical need or are designated orphan drugs to market when "the benefits to public health of making the medicinal product concerned immediately available on the market...outweigh the risk inherent in the fact that additional data are still required," the regulation says. EMEA clarified that "in the case of Sutent, this relates to the product's effect in terms of progression-free survival in patients with MRCC, for which a study is being conducted." The conditional MA is valid for one year with the assumption that it can be renewed at the end of the year or converted to a full MA once sufficient data is submitted. Final conditional marketing authorization of Sutent awaits confirmation by the EC, which "will normally be issued within 67 days from adoption of the [CHMP] opinion," EMEA said. The agency adds that the EMEA review of Sutent's marketing authorization application began Sept. 28, giving the oncologic a review time of 177 days. -Kathleen Michael |