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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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Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for LORBRENA
® (lorlatinib) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). The sNDA is based on data from the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in April 2021.
LORBRENA is a third-generation ALK inhibitor specifically developed to inhibit the most common tumor mutations that drive resistance to current medications and to address brain metastases. Up to 40% of people with ALK-positive lung cancer present with brain metastases.
Press release content from Business Wire. The AP news staff was not involved in its creation.
LORBRENA® (lorlatinib) sNDA in Previously Untreated ALK-Positive Lung Cancer Accepted for Priority Review by U.S. FDA
December 28, 2020 GMT
NEW YORK (BUSINESS WIRE) Dec 28, 2020
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for LORBRENA ® (lorlatinib) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). The sNDA is based on data from the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in April 2021.