Shots:

• The approval is based on the ADVL0912 study assessing Xalkori in 121 patients aged 1-21yrs. that included 26 patients with r/r- systemic ALK+ ALCL prior treated with at least one systemic treatment
• The study showed 88% ORR. Among 23 patients- who achieved a response- 39% maintained their response for at least 6mos. and 22% maintained their response for at least 12mos.
• Xalkori is a TKI and has received the FDA’s BTD for ALK+ ALCL in May’2018. Additionally- EMA has agreed to a PIP for the therapy to treat pediatric patients with r/r systemic ALK+ ALCL

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to­ read full press release/ article | Ref: Pfizer | Image: The Bangkok Post