Zacks_Analysts' Blog : Pfizer Seeks EU Approval for Axitinib - Analyst Blog

Pfizer Inc. (PFE) recently announced that its regulatory filing for oncology candidate, axitinib, has been accepted by the European Medicines Agency (EMA). Pfizer is seeking EU approval for the use of axitinib in treatment-failed patients with advanced renal cell carcinoma (RCC).

The regulatory filing was based on phase III data from the AXIS 1032 trial. The AXIS 1032 trial, which was conducted in patients with previously treated advanced renal cell carcinoma (RCC), showed that patients in the axitinib arm experienced a significant improvement in progression free survival (median of 6.7 months versus 4.7 months) compared to patients being treated with Bayer/Onyx Pharma’s (BAYRY/ONXX) Nexavar (sorafenib).

Pfizer reported that progression free survival was significantly longer in the axitinib arm irrespective of prior treatment with Sutent or cytokines. The company noted that axitinib lengthened median progression free survival to more than a year in the subset of patients who were previously treated with cytokines. Results from the study will be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO).

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 including tofacitinib, Prevnar/Prevenar 13 and Eliquis.

Pfizer will face additional challenges later this year with the loss of US exclusivity on Lipitor in November.