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Association details:
Biomarker:ALK positive
Cancer:Lymphoma
Drug:Xalkori (crizotinib) (ALK inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

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.
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

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.
DOI:
10.1093/jnci/djt378