FDA ACCEPTS SUPPLEMENTAL NEW DRUG APPLICATION FOR PFIZER’S XALKORI® (CRIZOTINIB) FOR THE TREATMENT OF PEDIATRIC ALK-POSITIVE ANAPLASTIC LARGE CELL LYMPHOMA
Published date:
09/23/2020
Excerpt:
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the Company’s supplemental New Drug Application(sNDA)for XALKORI® (crizotinib) for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.
Evidence Level:
Sensitive: C1 - Off-label
(Approved for Non-Hodgkin’s Lymphoma)
New
Excerpt:
XALKORI is a kinase inhibitor indicated for the treatment of…pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.
Crizotinib in advanced, chemoresistant anaplastic lymphoma kinase-positive lymphoma patients
Excerpt:
Crizotinib exerted a potent antitumor activity with durable responses in advanced, heavily pretreated ALK+ lymphoma patients, with a benign safety profile.