Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adults

 Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adults

Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adults

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

 

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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