Pfizer Reports the US FDA’s Acceptance of Xalkori’s (crizotinib) sNDA for Pediatric Patients with R/R Systemic ALCL

Shots:

• The US FDA has accepted and granted PR to the sNDA of Xalkori for pediatric patients with r/r systemic ALCL that is ALK+. The FDA submission is based on P-I/II ADVL0912 study assessing the maximum dose & clinical activity of therapy with r/r solid tumors ALCL
• The submission is also supported by the A8081013 study assessing Xalkori n pediatric and adult patients with advanced malignancies known to be ALK+ other than NSCLC and included patients with r/r ALCL. If approved, Xalkori would be the 1st biomarker-driven therapy for pediatric ALK+ ALCL
• The FDA’s submission is in addition to the EMA’s agreement on PIP for Xalkori for pediatric patients with r/r systemic ALK+ ALCL. Xalkori is a TKI indicated for metastatic NSCLC whose tumors are ALK+ or ROS1+ as detected by an FDA-approved test and has received FDA’s BTD for the ALK+ ALCL in May’2018

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