Xalkori® Receives FDA Breakthrough Therapy Designation for Anaplastic Large Cell Lymphoma
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Xalkori® (crizotinib) for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.
The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a medicine if it is intended to treat a serious or life-threatening disease and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. The Breakthrough Therapy designation is distinct from the FDA’s other mechanisms to expedite drug development and review.
Biomarkers & Medicines to Target Them
Not all cancer cells are alike. They may differ from one another based on what genes have mutations. By testing an individual’s lung cancer for specific unique biomarkers or genomic alterations doctors can identify genetic mutations or the proteins they produce and offer the most personalized treatment approach utilizing precision medicines. Precision cancer medicine uses targeted drugs and immunotherapies engineered to directly attack the cancer cells with specific abnormalities, leaving normal cells largely unharmed. Precision cancer medicines can be used both instead of and in addition to chemotherapy to improve treatment outcomes.
About Anaplastic Large Cell Lymphoma
Anaplastic large cell lymphoma (ALCL) is a rare type of non-Hodgkin lymphoma (NHL), but one of the more common subtypes of T-cell lymphoma. ALCL comprises about two percent of all NHLs and approximately 20 percent of all T-cell lymphomas.1,2 Some individuals with ALCL are ALK-positive and can be targeted with precision cancer medicines.
About Xalkori (crizotinib)
Xalkori is a tyrosine kinase inhibitor (TKI) precision cancer medicine currently indicated for the treatment of patients with (ALK)-positive. metastatic non-small cell lung cancer. The ALK mutation is responsible for initiating and promoting cancer growth and is directly targeted by Xalkori. Clinical studies have demonstrated that Xalkori has anti-cancer activity in ALK positive ALCL patients.3
- Drexler HG, Gignac SM, von Wasielewski R, et al. Pathobiology of NPM-ALK and variant fusion genes in anaplastic large cell lymphoma and other lymphomas. Leukemia 2000;14:1533–59.
- Lymphoma Research Foundation. Getting the Facts. Anaplastic Large Cell Lymphoma. https://www.lymphoma.org/wp-content/uploads/2018/04/LRF_FACTSHEET_ANAPLASTIC_LARGE_CELL_LYMPHOMA.pdf. Accessed May 2018.
- Mossé, Yael & D. Voss, Stephan & S. Lim, Megan & Rolland, Delphine & Minard, Charles & Fox, Elizabeth & Adamson, Peter & Wilner, Keith & Blaney, Susan & J. Weigel, Brenda. (2017). Targeting ALK With Crizotinib in Pediatric Anaplastic Large Cell Lymphoma and Inflammatory Myofibroblastic Tumor: A Children’s Oncology Group Study. Journal of Clinical Oncology. 35. JCO.2017.73.483.
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