The pharma giant Pfizer Inc. has reportedly declared that the U.S. Food and Drug Administration (US FDA) has approved the sNDA (supplemental New Drug Application) for XALKORI® (crizotinib) for the treatment of children of 1 year of age and older and young adults with refractory, or relapsed systemic ALCL (anaplastic large cell lymphoma) that is ALK (anaplastic lymphoma kinase)-positive. Interestingly, the safety and effectiveness of XALKORI is still not established in older adults with refractory or relapsed systemic ALK-positive ALCL. Anaplastic large cell lymphoma is a form of non-Hodgkin lymphoma, or NHL, and accounts for nearly 30% of NHL cases in young people, with approximately 90% of ALCL cases in this age group being ALK-positive.

Speaking on which, Chris Boshoff, M.D., Ph.D., CDO, Oncology, for Pfizer Global Product Development said that the company is proud and happy to deliver the first-ever biomarker-driven technological therapy for young adults and children with ALCL. XALKORI offers a new meaningful treatment option for patients with refractory or relapsed ALK-positive ALCL. XALKORI has transformed the way to treat ALK-positive non-small CLC (Cell Lung Cancer) as the first-ever biomarker-driven therapy and this approval validates a notable milestone in their journey to continue to chase the science to understand and address cancers with massive unmet needs. 

This launch marks a milestone for the company, as while many patients having ALK-positive ALCL respond positively to chemotherapy and other traditional routes of treatment, and even experience long-term remission, some patients are still prone to relapsing or may require alternative approaches for treatment.

The U.S. FDA approval has been given based on positive results from ADVL0912 (NCT00939770) an open-label, single-arm, multicenter, study conducted with 121 patients of ages ranging from 1 to 21 years, which had 26 patients with problems of relapsed or refractory, cyclical ALK-positive ALCL even after at least one proper cyclical treatment.

Treatment with  this drug apparently yielded an objective response rate (ORR) of 88%. Among the 23 young adults who achieved a response, nearly 39% maintained this response for a minimum of 6 months and 22% maintained this response for a almost a year.

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https://www.businesswire.com/news/home/20210114006005/en/Pfizer%E2%80%99s-XALKORI%C2%AE-crizotinib-Approved-by-FDA-for-ALK-positive-Anaplastic-Large-Cell-Lymphoma-in-Children-and-Young-Adults