15 January 2021 - - The US Food and Drug Administration approved the supplemental New Drug Application 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 that is anaplastic lymphoma kinase -positive, US-based pharmaceutical company Pfizer Inc. (NYSE: PFE) said.

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 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, 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 included neutropenia, lymphopenia and thrombocytopenia.

Grade 4 laboratory abnormalities included neutropenia, lymphopenia and thrombocytopenia.

In Study ADVL0912, visual disorders occurred in 46% of 121 patients treated with XALKORI, including 65% of the 26 patients diagnosed with ALCL.

Xalkori received Breakthrough Therapy designation from the FDA for the ALK-positive ALCL indication in May 2018.

The European Medicines Agency has agreed to a Paediatric Investigational Plan for XALKORI including the treatment of pediatric patients with relapsed or refractory systemic ALK-positive ALCL.

This agreement provides a path for a potential regulatory submission for Xalkori in pediatric patients with relapsed or refractory ALK-positive ALCL in the European Union.

Xalkori is a tyrosine kinase inhibitor indicated for the treatment of patients with metastatic NSCLC whose tumors are ALK- or ROS1-positive as detected by an FDA-approved test.

In addition to the United States, Xalkori has received approval for patients with ALK-positive NSCLC in more than 90 countries including Australia, Canada, China, Japan, South Korea and the European Union. Xalkori is also approved for ROS1-positive NSCLC in more than 70 countries.

Xalkori is indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is ALK-positive.

The safety and efficacy of Xalkori have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.