Zacks_Analysts' Blog : FDA Approves Pfizer's Xalkori - Analyst Blog

Pfizer Inc. (PFE) recently received a major boost with the US Food and Drug Administration (FDA) granting approval to Xalkori (crizotinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test.

Xalkori’s approval was based on data from 255 patients with locally advanced or metastatic ALK-positive NSCLC across two multi-center, single-arm studies, including a phase II study (PROFILE 1005) and a Part 2 expansion cohort of a phase I study (Study 1001).

The FDA simultaneously approved Abbott Labs’ (ABT) Vysis ALK Break Apart FISH Probe Kit which is a companion diagnostic test that identifies the presence of the ALK fusion gene. Xalkori is available through several specialty pharmacies.

Xalkori’s approval is a major positive for Pfizer. With the company slated to face generics for Lipitor in the US from November 2011, Xalkori’s approval is welcome news. It is estimated that about 3-5% of NSCLC tumors are ALK-positive - this translates into approximately 6,500 to 11,000 NSCLC patients in the US every year.

With Xalkori gaining accelerated FDA approval, Pfizer is currently conducting post-marketing studies to evaluate the product’s clinical benefit. Xalkori is in confirmatory, randomized, open-label phase III studies comparing its efficacy and safety with standard of care chemotherapy (pemetrexed or docetaxel) in patients with previously treated advanced ALK-positive NSCLC.

Meanwhile, Pfizer is seeking approval for Xalkori in several territories including Japan, Korea, the EU and Switzerland.

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 the success of drug development.