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Pfizer's (PFE) Xalkori Gets FDA Nod for Rare Lymphoma in Kids

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Pfizer (PFE - Free Report) announced that the FDA has approved its supplemental new drug application (sNDA), seeking approval of its cancer drug Xalkori for a new indication. The sNDA sought approval of Xalkori for the treatment of relapsed or refractory ALK-positive anaplastic large cell lymphoma (ALCL), a rare form of non-Hodgkin lymphoma (NHL), in pediatric patients and young adults.

Xalkori is presently approved to treat metastatic ALK- or ROS1-positive NSCLC. It is not approved for relapsed or refractory, systemic ALK-positive ALCL in older adults.

The approval was based on data from the Study ADVL0912, which evaluated 121 patients between the ages of 1 and 21. The study included 26 patients with relapsed/refractory ALK-positive ALCL after at least one systemic treatment. Data from the study demonstrated that treatment with Xalkori led to an objective response rate of 88% in such patients.

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.

Pfizer’s stock is down 9.5% in the past year against 3.1% increase for the industry.



Xalkori is one of the key oncology drugs in Pfizer’s portfolio. The drug generated sales of $409 million in the nine months of 2020, reflecting growth of 8% year over year. A potential approval for the drug’s label expansion into the hematologic indication will boost the drug’s sales further. ALCL accounts for approximately 30% NHL cases in young people with approximately 90% of these cases being ALK-positive. Xalkori is also being developed for treating several other oncology indications.

Xalkori is a key drug in Pfizer’s oncology portfolio. Other important cancer drugs in Pfizer’s portfolio are Ibrance, Sutent and Inlyta. In the past 4-5 years, Pfizer has gained approval for several innovative medicines like Daurismo, Lorbrena, Vizimpro, Talzenna, Besponsa, and Mylotarg. Importantly, Pfizer is venturing into the oncology biosimilars space. Biosimilar versions of Roche’s (RHHBY - Free Report) cancer drugs Herceptin (trade name: Trazimera), Avastin (trade name: Zirabev) and Rituxan (trade name: Ruxience) were launched in the United States in early 2020.

Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some better-ranked large drug/biotech stocks are Merck (MRK - Free Report) and Alexion Pharmaceuticals (ALXN - Free Report) , both with a Zacks Rank #2 (Buy).

Merck’s shares have risen 3.5% in the past six months while its earnings estimates for 2021 have risen 1.5% over the past 90 days.

Alexion’s shares have gained 43.1% in the past six months while its earnings estimates for 2021 have risen 2.9% over the past 90 days.

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