Xalkori for the treatment of pediatric ALK-positive anaplastic large cell lymphoma: FDA has accepted supplemental new drug application
The FDA ( U.S. Food and Drug Administration ) has accepted and granted priority review to the supplemental New Drug Application( sNDA ) for Crizotinib ( Xalkori ) for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma ( ALCL ) that is anaplastic lymphoma kinase ( ALK )-positive.
Anaplastic large cell lymphoma is a rare type of non-Hodgkin lymphoma ( NHL ), divided into ALK-positive or ALK-negative disease.
Though the five-year survival rate for children with cancer in the U.S. is now the highest it’s ever been at 80%, children with cancer continue to face challenges in treating their disease, including rare tumor types, variations in medicine response and prolonged risk of side effects.
The FDA submission is supported by the results from Study ADVL0912 and Study A8081013.
Study ADVL0912 is a phase 1/2 study conducted in collaboration with the Children’s Oncology Group ( COG ), evaluating the maximum dose that is safe and tolerable, and assessing clinical activity in pediatric patients with relapsed or refractory solid tumors and ALCL.
Study A8081013 evaluated Crizotinib in pediatric and adult patients with advanced malignancies known to be ALK-positive other than non-small cell lung cancer ( NSCLC ) and included patients with relapsed or refractory ALCL.
These two studies have shown compelling antitumor activity in pediatric and adult patients who received Crizotinib.
This FDA submission is in addition to the European Medicines Agency’s agreement on a Pediatric Investigational Plan ( PIP ) for Xalkori including the treatment of pediatric patients with relapsed or refractory systemic ALK-positive ALCL.
This decision represents a step forward for potential regulatory submission for Xalkori in pediatric patients with relapsed or refractory ALK-positive ALCL in the European Union.
Crizotinib is a tyrosine kinase inhibitor ( TKI ). ( Xagena )
Source: Pfizer, 2020