CHMP recommends the expanded approval of Xalkori for two more uses; i. to treat certain children with anaplastic large cell lymphoma (ALCL), and ii. inflammatory myofibroblastic tumor (IMT)
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xalkori
The marketing authorisation holder for this medicinal product is Pfizer Europe MA.
The CHMP adopted 2 new indications for the treatment of paediatric patients with anaplastic large cell lymphoma (ALCL) or inflammatory myofibroblastic tumour(IMT).
For information, the full indications for Xalkori will therefore be as follows: Xalkori as monotherapy is indicated for: i. The first-line treatment of adults with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC). ii. The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). iii. The treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC). iv. The treatment of paediatric patients (age greater than 6 to less than 18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) .vi. The treatment of paediatric patients (age greater than 6 to less than 18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK)-positive unresectable inflammatory myofibroblastic tumour (IMT).
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