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January 15, 2021

FDA approves Pfizer’s Xalkori in ALCL in children, young adults

The US Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Pfizer’s Xalkori (crizotinib) for treating paediatric patients aged one year and above and young adults with anaplastic lymphoma kinase (ALK)-positive relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL).

The US Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Pfizer’s Xalkori (crizotinib) for treating paediatric patients aged one year and above and young adults with anaplastic lymphoma kinase (ALK)-positive relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL).

The latest development derives from results of Study ADVL0912, which showed Xalkori treatment resulted in an objective response rate of 88%.

The multicentre, single-arm, open-label study enrolled 121 patients aged between one and 21 years and included 26 patients with relapsed or refractory, systemic ALK-positive ALCL after at least one systemic treatment.

Furthermore, Xalkori’s safety profile in ALK-positive ALCL in children and young adults was observed to be similar to those in patients suffering from ALK-positive and ROS1-positive metastatic NSCLC.

Pfizer Global Product Development Oncology chief development officer Chris Boshoff said: “We are proud to deliver the first biomarker-driven therapy for children and young adults with ALCL. Xalkori offers a meaningful new treatment option for young patients with relapsed or refractory ALK-positive ALCL.

“Xalkori transformed the treatment of ALK-positive non-small cell lung cancer as the first biomarker-driven therapy for that disease, and this approval is a notable milestone in our journey to continue to follow the science to address cancers with significant unmet need.”

Xalkori’s safety and efficacy in older adults with relapsed or refractory, systemic ALK-positive ALCL remain unestablished.

Last September, Pfizer secured priority review from the US FDA for Xalkori to treat relapsed or refractory systemic ALK-positive ALCL in children.

In a separate development, the US Food and Drug Administration (FDA) cleared clinical-stage cell therapy company Vor Biopharma’s Investigational New Drug (IND) application for an eHSC therapy candidate, VOR33, for treating acute myeloid leukaemia (AML).

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