Pfizer Seeks Xalkori's Label Expansion, Gets Priority Review

Pfizer Inc. PFE announced that the FDA has accepted and granted priority review to its supplemental new drug application(sNDA) for its lung cancer drug, Xalkori (crizotinib). The sNDA is seeking label expansion of the drug to include pediatric patients with relapsed or refractory (r/r) anaplastic lymphoma kinase (“ALK”)-positive systemic anaplastic large cell lymphoma (“ALCL”). The cancer is a rare form of non-Hodgkin lymphoma.

A decision related to approval of the sNDA from the FDA is expected in January 2021. Please note that Xalkori is presently approved for treating metastatic non-small cell lung cancer (“NSCLC”) whose tumors are ALK-positive or ROS1-positive.

The sNDA is supported by data from two early-stage studies — Study ADVL0912 and Study A8081013. Data from these studies demonstrated compelling antitumor activity in pediatric and adult patients treated with Xalkori.

Pfizer is also developing the drug for pediatric patients in Europe under the European Medicines Agency’s Pediatric Investigational Plan for r/r systemic ALK-positive ALCL.

Shares of Pfizer have lost 8.1% year to date compared with the industry’s decline of 0.8%.

Xalkori is one of the key oncology drugs in Pfizer’s portfolio. The drug generated sales of $287 million in the first half of 2020, reflecting growth of 12% year over year. A potential approval for the drug’s label expansion into the hematologic indication will boost the drug’s sales further.

The drug is also being developed for treating several other oncology indications. A phase I/II study is evaluating the drug in combination with Novartis’ NVS Mekinist (trametinib) as a potential treatment for ALK-positive advanced NSCLC. Another phase II/III study is evaluating the drug as monotherapy for treating children and adolescents with myofibroblastic tumors. A phase III study is evaluating the drug in combination with standard therapy for treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma.

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Zacks Rank & Stocks to Consider

Pfizer currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharma/biotech sector include Emergent Biosolutions Inc. EBS and Horizon Therapeutics HZNP, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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