Zacks_Analysts' Blog : Standard FDA Review for Pfizer Drug - Analyst Blog

Pfizer Inc. (PFE) recently announced that its regulatory application for oncology candidate, axitinib has been accepted for standard review by the US Food and Drug Administration (FDA). The company is seeking approval for the treatment of patients with advanced renal cell carcinoma (RCC).

The regulatory application was based on data from the phase III AXIS 1032 study which compared axitinib with Onyx Pharmaceuticals/Bayer’s (ONXX/BAYRY) Nexavar (sorafenib).

Earlier this month, the European Medicines Agency (EMA) also accepted Pfizer’s regulatory filing for axitinib. Pfizer is seeking EU approval for the use of axitinib in treatment-failed patients with advanced renal cell carcinoma.

The approval of axitinib would provide advanced renal cell carcinoma patients, especially previously-treated patients, with an additional treatment option. According to Pfizer, kidney cancer is diagnosed in about 210,000 people every year with about 102,000 expected to die from the disease.

Although significant progress has been made in the treatment of kidney cancer, five-year survival rates still remain low at about 20%. Pfizer already has two drugs approved for kidney cancer – Sutent and Torisel.

Pfizer is evaluating axitinib for other tumor types as well and is currently conducting a phase III study with the candidate in treatment-naïve and previously treated patients suffering from mRCC. Axitinib is also in a randomized phase II study for hepatocellular carcinoma (HCC).

Neutral on Pfizer

We currently have a Neutral recommendation on Pfizer, which carries a Zacks #3 Rank (short-term Hold rating). While near-term earnings growth will come in the form of cost cutting and share repurchases, longer-term growth will be dependent on successful drug development. 2011 should be a catalyst-filled year for the company, which is expecting to present phase III data on several candidates. Pfizer will, however, face additional challenges later this year with the loss of US exclusivity on Lipitor in November.