Xalkori approved by the FDA for treatment of pediatric and young adults with relapsed/refractory ALK positive anaplastic large cell lymphoma.- Pfizer.

Pfizer Inc. announced that the FDA approved the supplemental New Drug Application (sNDA) for Xalkori (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. The safety and efficacy of Xalkori have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. ALCL is a rare form of non-Hodgkin lymphoma (NHL) and accounts for approximately 30% of cases of NHL in young people Approximately 90% of ALCL cases in young people are ALK-positive. Although the majority of people with ALK-positive ALCL respond well to chemotherapy and experience long-term remission, a number of patients will unfortunately relapse or require alternative treatment approaches. The FDA approval is based on results from Study ADVL0912 (NCT00939770), a multicenter, single arm, open-label study in 121 patients between the ages of 1 and 21 that included 26 patients with relapsed or refractory, systemic ALK-positive ALCL after at least one systemic treatment. Treatment with Xalkori resulted in an objective response rate of 88%. Among the 23 patients who achieved a response, 39% maintained their response for at least 6 months and 22% maintained their response for at least 12 months. The safety profile of Xalkori in ALK-positive ALCL in children and young adults is generally consistent with that observed in patients with ALK-positive and ROS1-positive metastatic NSCLC. The most common adverse reactions ( greater than 35%), excluding laboratory abnormalities, were diarrhea, vomiting, nausea, vision disorder, headache, musculoskeletal pain, stomatitis, fatigue, decreased appetite, pyrexia, abdominal pain, cough and pruritis. The most common Grade 3 or 4 laboratory abnormalities ( greater than 15%) included neutropenia, lymphopenia and thrombocytopenia. Grade 4 laboratory abnormalities ( greater than 15%) included neutropenia (62%), lymphopenia (35%) and thrombocytopenia (19%). In Study ADVL0912, visual disorders occurred in 46% of 121 patients treated with Xalkori, including 65% of the 26 patients diagnosed with ALCL.