All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.
The lym Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the lym Hub cannot guarantee the accuracy of translated content. The lym and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The Lymphoma & CLL Hub is an independent medical education platform, sponsored by AbbVie, BeOne Medicines, Johnson & Johnson, Roche, and Sobi, and supported through educational grants from Bristol Myers Squibb, Incyte, Lilly, and Pfizer. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out moreCreate an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View lym content recommended for you
The U.S. Food and Drug Administration (FDA) has accepted and granted priority review of a supplemental new drug application for crizotinib, for use in pediatric patients with anaplastic lymphoma kinase (ALK)-positive, relapsed or refractory (R/R) systemic anaplastic large cell lymphoma (ALCL). The Prescription Drug User Fee Act (PDUFA) decision date has been set for January 2021.
Crizotinib, a small molecule inhibitor of ALK, is currently indicated for the treatment of patients with ALK-positive or c-ros oncogene 1 (ROS1)-positive metastatic non-small cell lung cancer (NSCLC). The FDA previously granted crizotinib a breakthrough therapy designation for ALK-positive ALCL in May 2018, and the European Medicines Agency (EMA) agreed a pediatric investigation plan for crizotinib for the same indication in December 2019.
The FDA submission is based on results from two studies which showed compelling anti-tumor activity in patients receiving crizotinib, including children with R/R AKL-positive ALCL. The first study, ADVL0912 (NCT00939770), is a phase I/II trial conducted in collaboration with the Children’s Oncology Group (COG) and the National Cancer Institute (NCI), evaluating tolerability and clinical activity of crizotinib in pediatric patients with ALK-positive R/R solid tumors or ALCL. The second study, A8081013 (NCT01121588), is a phase Ib trial evaluating crizotinib activity in children and adults with ALK-positive tumors other than NSCLC, including those with R/R ALCL.
Despite high survival rates, many children with ALK-positive ALCL relapse. If approved, crizotinib would provide the first biomarker-driven treatment option for pediatric ALK-positive ALCL, marking a significant step towards targeted therapies for these patients.
References
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content
Your opinion matters
Which of the following would most increase your confidence in referring patients with R/R large B-cell lymphoma for CAR T-cell therapy?