publication date: Sep. 22, 2017

In a 6-6 vote, ODAC says “maybe” to Sutent for adjuvant kidney cancer—But at FDA “Maybe” has meaning

By Paul Goldberg

With frustrating photo finish voting results—6-6—still on the screen, FDA’s cancer czar Richard Pazdur delivered an acerbic thank-you to members of the agency’s Oncologic Drugs Advisory Committee:

“Well, that’s the end vote, it makes our job definitely easier,” said Pazdur, director of the FDA’s Oncology Center of Excellence, who gets sarcastic sometimes.

The complicated questions raised in Pfizer’s application to move Sutent (sunitinib), a drug approved for metastatic renal cell carcinoma into the adjuvant setting, were now bounced back to the agency.

At the ODAC meeting Sept. 19, the committee members mostly agreed that the S-TRAC trial of Sutent vs. placebo was well designed and well executed. Beyond that, things got cloudy fast:

The endpoint, disease-free survival, has been used to approve drugs for breast cancer, colon cancer and melanoma in the adjuvant setting. Can its usefulness be extrapolated to renal cell carcinoma?

Another clinical trial, ASSURE, found that Sutent and another agent, Bayer’s Nexavar (sorafenib), didn’t work in adjuvant renal cell carcinoma. A third trial, PROTECT, which evaluated Novartis’s Votriant (pazopanib), also failed to meet its primary endpoint. Pfizer ended up having to show how the risk groups and … Continue reading In a 6-6 vote, ODAC says “maybe” to Sutent for adjuvant kidney cancer—But at FDA “Maybe” has meaning

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