Pfizer's ALK Inhibitor Xalkori Receives FDA Approval for Expanded Indication in Pediatric and Young Adult ALK-Positive ALCL

Pfizer Announces FDA Approval of Xalkori (crizotinib) for Expanded Indication in Pediatric and Adolescent Patients with ALK-Positive Systemic Anaplastic Large Cell Lymphoma (ALCL)Pfizer announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Xalkori (crizotinib) for the treatment of pediatric and adolescent patients with ALK-positive systemic anaplastic large cell lymphoma (ALCL). These patients have relapsed or refractory disease. The press release noted that this represents the first biomarker-driven precision therapy for patients with ALCL.

Anaplastic Large Cell Lymphoma (ALCL) is a rare type of non-Hodgkin lymphoma (NHL), accounting for approximately 30% of NHL cases in young people. About 90% of ALCL cases in this population are ALK-positive. Although most patients with ALK-positive ALCL respond well to chemotherapy and achieve long-term remission, many unfortunately experience relapse or require alternative treatment approaches.

Xalkori is a tyrosine kinase inhibitor (TKI) that has been approved in multiple countries and regions for the treatment of ALK-positive and ROS1-positive non-small cell lung cancer. In 2018, it received Breakthrough Therapy Designation from the U.S. FDA for the treatment of pediatric and adolescent patients with ALK-positive anaplastic large cell lymphoma (ALCL).

The FDA approval was based on the results of a multicenter, single-arm, open-label study involving 26 patients with relapsed or refractory ALK-positive anaplastic large cell lymphoma (ALCL) who had received at least one prior systemic therapy. Treatment with Xalkori achieved an objective response rate of 88%. Among the 23 patients who responded, 39% maintained their response for at least 6 months, and 22% maintained their response for at least 12 months.

“We are proud to offer the first biomarker-driven therapy for pediatric and adolescent patients with ALCL. Xalkori provides them with a meaningful new treatment option,” said Dr. Chris Boshoff, Chief Development Officer of Global Product Development at Pfizer Oncology. “As the first biomarker-driven therapy, Xalkori has transformed the treatment of ALK-positive non-small cell lung cancer. This approval marks another milestone in our ongoing commitment to follow the science and address significant unmet needs in cancer care.”

Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a licensed healthcare provider at a reputable hospital.

References:

[1] Pfizer’s XALKORI® (crizotinib) Approved by FDA for ALK-positive Anaplastic Large Cell Lymphoma in Children and Young Adults. Retrieved January 14, 2021, from https://www.businesswire.com/news/home/20210114006005/en

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