US regulator approves new use for Pfizer's Sutent

The US regulator has approved a new use for Pfizer’s Sutent in kidney cancer, despite the reservations from some of its expert advisers.

In September the FDA’s Oncologic Drug Advisory Committee (ODAC) could not decide whether Sutent should be approved in the new use.

Pfizer asked for approval as an adjuvant in recurrent renal cell carcinoma (RCC) patients at high risk of recurrent renal cell carcinoma following surgery to remove of the cancerous kidney.

The 12-strong ODAC was split on whether the clinical results from the S-TRAC study showed a benefit that outweighed the risks of treatment.

The study 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 more likely to suffer serious side effects, with more than 60% reporting side effects of grade 3 or above, compared with 21% of patients treated with placebo.

However in the absence of any other therapy approved in this indication, the FDA has decided to grant the licence. It is not obliged to follow the advice of its committees, but usually does.

Sutent (sunitinib) is one of Pfizer’s older approved drugs, first gaining a licence for stomach and kidney cancer in 2006, and a rare type of pancreatic cancer in 2011.

Sales are at blockbuster level – in the third quarter they were up 6% compared with the same period last year, to $276 million.

Facing stiff competition from the likes of Novartis’ Afinitor and Bayer’s Nexavar, first approval in a new indication will help Pfizer build sales of a well-established drug, which still has around four years left before its patent expires.

Daniel George, MD, study investigator and medical oncologist at Duke University Medical Center, said: “Some patients who have undergone surgery for locally advanced RCC are at high risk of recurrence and often fear their disease returning.”

“This adjuvant therapy is the first-of-its-kind and a remarkable clinical development for these patients who before today, have been restricted to a wait and see approach.”