Labeling for Pfizer's Sutent now includes data demonstrating the oncologic's survival benefit over standard therapy for first-line treatment of advanced renal cell carcinoma, the company announced Feb. 8.

Sutent (sunitinib) was originally approved Jan. 26, 2006, for treatment of advanced RCC under the accelerated approval provision, based on partial response rates and duration of response. With the new labeling, the accelerated approval has been converted to regular approval.

The updated labeling of the kinase inhibitor was based on results of a randomized Phase III trial, which was published in the Jan. 11, 2007 issue of the New England Journal of Medicine.

The trial included 750 treatment-naive patients with metastatic RCC receiving either Sutent or interferon-alfa (IFN infinity), the current standard of care. Patients on sunitinib achieved a median progression-free survival of 11 months - more than double the five-month median progression-free survival observed with the comparator, study results show.

Common treatment-related adverse events included fatigue, diarrhea, nausea, altered taste, mucositis/stomatitis, hypertension, anorexia and bleeding.

Labeling warns that women of child bearing age who are (or become) pregnant during therapy should be informed of the potential for fetal harm while on Sutent. In addition, patients with concomitant cardiac conditions should be carefully monitored for clinical signs and symptoms of congestive heart failure.

Sutent was the first oncology NME approved by FDA for two indications simultaneously - RCC and gastrointestinal stromal tumors after disease progression on or intolerance to Novartis' Gleevec (imatinib) (¹ Also see "Pfizer's Sutent Receives Dual Approvals For Kidney Cancer & Stomach Cancer" - Pink Sheet, 26 January, 2006.).

Pfizer currently has 50 Phase I, II and III trials ongoing or completed for Sutent in multiple cancer indications. Sunitinib generated $219 million in sales in 2006, its first year on the market, and Pfizer is looking to the oncologic as a key driver of sales going forward, with plans to launch it in 20 additional countries this year.

Wyeth has initiated trials evaluating its renal cell carcinoma candidate Torisel (temsirolimus) in patients who fail Sutent and Bayer's Nexavar (sorafenib) (² Also see "Torisel, Sutent, Nexavar Combinations Are “Future” Of RCC Treatment – Wyeth Exec" - Pink Sheet, 10 January, 2007.).

- Tamra Sami (t.sami@elsevier.com)

Sutent Labeling Updated To Reflect First-Line Renal Cell Carcinoma Data

More from Archive

More from Pink Sheet