XALKORI is the first biomarker-driven therapy for relapsed or refractory ALCL in young people Pfizer Inc. today announced that the U.S. Food and Drug Administration approved the supplemental New Drug Application for XALKORI ® for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase … XALKORI is the first biomarker-driven therapy for relapsed or refractory ALCL in young people Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for XALKORI
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XALKORI is the first biomarker-driven therapy for relapsed or refractory ALCL in young people
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for XALKORI (crizotinib) 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 anaplastic lymphoma kinase (ALK)-positive. The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. ALCL is a rare form of non-Hodgkin lymphoma (NHL) and accounts for approximately 30% of cases of NHL in young people.
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DUBLIN, Dec. 21, 2020 /PRNewswire/ Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company has initiated the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for JZP-458 for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in adult and pediatric patients who have developed hypersensitivity or silent inactivation to
E. coli-derived asparaginase.
The BLA was initiated and will be reviewed under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA s Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients.