Pfizer PFE 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 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 and Alexion Pharmaceuticals ALXN, 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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