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Pfizer Inc. (PFE) - free report >>
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Pfizer Inc. (PFE) - free report >>
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Pfizer's Lung Cancer Drug Xalkori Label Expanded in the EU
Pfizer, Inc. (PFE - Free Report) announced that its lung cancer drug Xalkori has been approved for an additional indication by the European Commission (EC).
The EC has approved Xalkori for the treatment of adult patients with advanced NSCLC whose tumors are ROS1-positive
We note that Xalkori is already approved in the EU for the first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC and for the treatment of adults with previously treated ALK-positive advanced NSCLC. It is also approved in the U.S. for the treatment of metastatic NSCLC in patients whose tumors are ALK-positive. In March this year, the drug received approval in the U.S. for expanded use in metastatic NSCLC in patients whose tumors are ROS1-positive.
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With the latest approval in the EU, Xalkori can now be used to treat patients with either ALK positive or ROS1-positive advanced NSCLC in both the EU and U.S.
The EC approval was based on a positive opinion issued by European Medicine’s Agency’s Committee for Medicinal Products for Human Use (CHMP), backed by positive efficacy and safety data from a multicenter phase I study.
Pfizer posted worldwide Xalkori sales of $275 million in the first half of 2016, up 20% from the year-ago figure. The expanded indication of the drug should drive sales further.
NSCLC is a difficult-to-treat disease, accounting for about 85% of lung cancer cases. At present, the lung cancer treatment market is highly crowded with drugs like Opdivo, Keytruda, Alecensa, Zykadia and Taxotere among others.
Currently, Pfizer carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Actelion Ltd. , Geron Corporation (GERN - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . All these stocks sport a Zacks Rank #1 (Strong Buy).
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