Pfizer's Sutent Expanded Indication: 'Hope' Or 'False Hope'?

US FDA Oncologic Drugs Advisory Committee casts tie vote on proposed expansion of Sutent's renal cell carcinoma indication, mirroring debate FDA having internally.

FDA Advisory Committee Feature image — Oncologic Drugs Advisory Committee votes 6-6 on whether the risk-benefit profile for Sutent's indication expansion is acceptable.

The US FDA's Oncologic Drugs Advisory Committee, just like the agency itself, struggled to determine whether Pfizer Inc.'s Sutent (sunitinib) provides clinical benefit as an adjuvant treatment of renal cell carcinoma, offering no definitive recommendation.

The committee tied with a 6-6 vote Sept. 19 on whether the risk-benefit profile was acceptable as adjuvant treatment in...