Chemotherapy drug crizotinib usage extended to children with ALCL or IMT

September 2022 Pharma News Nalinee Pathak

The Committee for Medicinal Products for Human Use (CHMP)  has recently recommended new terms for the market authorization of the medicinal product crizotinib, that is marketed by Pfizer under the brand name Xalkori.

The existing indications for the Xalkori monotherapy included:

  1. The first-line treatment of adults with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC);
  2. The treatment of adults with previously treated ALK‑positive advanced NSCLC;
  3. The treatment of adults with ROS1-positive advanced NSCLC.

The CHMP has adopted two new indications for crizotinib for paediatric patients with anaplastic large cell lymphoma (ALCL) or inflammatory myofibroblastic tumour (IMT). They are:

  1. The treatment of paediatric patients (age ≥6 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK) positive anaplastic large cell lymphoma (ALCL)
  2. The treatment of paediatric patients (age ≥6 to <18 years) with recurrent or refractory ALK-positive unresectable inflammatory myofibroblastic tumour (IMT)

The European public assessment report (EPAR) will publish the details of its usage. They will be made available in all official European Union languages once the European commission grants market authorisation.

Reference

https://www.ema.europa.eu/en/medicines/human/summaries-opinion/xalkori

X