FDA advisers split on new kidney cancer use for Pfizer's Sutent

Pfizer’s Sutent is well established in kidney cancer – but it may have run into trouble due to problems getting the FDA to approve a new use and a potential threat from a cancer immunotherapy rival.

Earlier this week, experts on the FDA’s Oncologic Drug Advisory Committee (ODAC) couldn’t decide whether Sutent (sunitinib) should be approved in patients after the removal of a cancerous kidney.

While the FDA is not bound to act on the advice of its advisory committees, the ODAC was split on whether the benefits of Sutent outweighed its risks in the new indication, with six members voting in favour and six voting against.

This hardly helps the regulator make a final decision on mixed study results, which showed patients treated with Sutent for one year did not relapse for a median of 6.8 years, compared with 5.6 years for placebo.

But on the other hand, Sutent patients were three times as likely to suffer serious side effects. More than 60% of patients treated with Sutent reported side effects of grade 3 or above, compared with 21% of placebo patients.

Pfizer has asked the FDA to widen Sutent’s label to include it as an adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy.

Sutent is a blockbuster, with sales of just over a billion dollars last year, but amid stiff competition from the likes of Novartis’ Afinitor and Bayer’s Nexavar, sales were down slightly compared with 2015.

And Bristol-Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab) combination has produced results showing it outperforms Sutent in a phase 3 trial in previously untreated kidney cancer.

Opdivo and Yervoy reduced the risk of death by 37% compared with Sutent in patients with previously untreated advanced or metastatic renal cell carcinoma.

The cancer immunotherapy combination also outperformed Sutent in terms of safety, with 46% of patients on the Opdivo/Yervoy arm reporting grade 3 or 4 adverse events, compared with 64% on the Sutent arm.

Pfizer also has a newer drug, Inlyta, approved in kidney cancer, and will hope that various combinations could help to build sales in this hotly contested disease area.