Pfizer's Sutent is the first oncologic new molecular entity to be approved for two indications simultaneously, FDA said.

Sunitinib was approved on Jan. 26 "for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to" Novartis' Gleevec (imatinib). Sutent also received accelerated approval for "the treatment of advanced renal cell carcinoma," ¹ labeling states.

Both indications were reviewed in less than six months; the NDAs were submitted to the agency on Aug. 10 (² Also see "Pfizer's Sutent Gets Fast-Track Status From FDA" - Pink Sheet, 10 August, 2005.).

With Sutent's approval, more than two weeks before the product's user fee date of Feb. 10, the product became the second drug approved for advanced renal cell carcinoma in just over a month. FDA approved Bayer/Onyx' Nexavar (sorafenib) for the same indication on Dec. 20 (³ Also see "Bayer/Onyx’ Nexavar Approved For Kidney Cancer" - Pink Sheet, 20 December, 2005.).

Both Nexavar and Sutent are approved for first-line use in renal carcinoma even though patients in the products' studies had been previously treated. Nexavar received a full approval based on progression-free survival while Sutent received an accelerated approval based on overall response rates and will have to submit confirmatory data.

During a same-day conference call announcing the approval, FDA declined to compare Nexavar and Sutent because the products have not been compared in head-to-head studies. FDA did venture to say that the two are similar in that they both represent an improvement in toxicity over previous therapy.

"In general...both of these drugs have more favorable toxicity profiles than conventional cytotoxic chemotherapies," Office of Oncology Drug Products Director Richard Pazdur said.

Division of Drug Oncology Products reviewer David Morse observed that Nexavar and Sutent "have a very, very similar pattern of activity across a number of growth factors that are seen in cells throughout the body."

"While there's some difference in the spectrum of specific binding to some of the receptor tyrosine kinases for these two compounds, it is not very different," Morse said.

However, "we do not at this particular time have specific information from the patients who were responders and those who were not responders as to their specific degree of affinity, or receptor expression that might explain why some responded and some did not," he said.

Pfizer previously hinted that Sutent would get favorable labeling, presumably in relation to Nexavar. CEO Hank McKinnell predicted it would be "better than we hoped for" (⁴ Also see "Pfizer Expects Favorable Labeling For Oncologic Sutent" - Pink Sheet, 5 January, 2006.).

- John Rancourt

Pfizer's Sutent Receives Dual Approvals For Kidney Cancer &amp; Stomach Cancer

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Pfizer's Sutent Receives Dual Approvals For Kidney Cancer & Stomach Cancer