EC Approves Pfizer's Inlyta

Pfizer Inc. (PFE - Analyst Report) recently announced European Commission (EC) approval of its renal cell cancer drug, Inlyta (axitinib). Inlyta gained approval from the EC for use in treatment-failed patients (prior treatment with Sutent (sunitinib or a cytokine) with advanced renal cell carcinoma (RCC).

Approval was largely expected as, earlier this year, the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) had issued a positive opinion regarding Inlyta.

Pfizer had announced the submission of its EU marketing application for Inlyta in June 2011. The regulatory filing was based on phase III data from the AXIS trial. The AXIS trial, which was conducted in patients with previously treated advanced renal cell carcinoma, showed that patients in the Inlyta arm experienced a significant improvement in progression free survival (median of 6.8 months versus 4.7 months) compared to patients being treated with Bayer/Onyx Pharma’s (BAYRY - Analyst Report)/(ONXX - Analyst Report) Nexavar (sorafenib).

The EU approval of Inlyta will provide advanced renal cell carcinoma patients, especially previously-treated patients, with an additional treatment option. We note that Inlyta gained approval earlier this year in the US. Other countries where Inlyta is already approved include Switzerland, Japan, Canada, Australia, and Korea. Pfizer is currently conducting a phase III study with Inlyta in treatment-naïve patients suffering from renal cell carcinoma. Besides Inlyta, Pfizer has two drugs approved for kidney cancer – Sutent and Torisel.

We currently have a Neutral recommendation on Pfizer, which carries a Zacks #3 Rank (short-term Hold rating). While near-term earnings will be driven by cost cutting efforts and share repurchases, longer-term growth will depend on the success of drug development.