FDA grants priority review to Xalkori for certain children with lymphoma
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The FDA granted priority review to crizotinib for the treatment of certain children with lymphoma, according to the agent’s manufacturer.
The designation applies to use of crizotinib (Xalkori; Pfizer, EMD Serono) for pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase (ALK) positive.
Crizotinib — an ALK tyrosine kinase inhibitor — is approved in the United States for treatment of patients with metastatic non-small cell lung cancer whose tumors are ALK positive or ROS1 positive.
A supplemental new drug application seeks approval of the agent for pediatric ALK-positive anaplastic large cell lymphoma. The FDA previously granted breakthrough therapy designation to the drug for this indication.
Anaplastic large cell lymphoma is a rare type of non-Hodgkin lymphoma. Approximately 80% of children with this malignancy survive 5 years; however, rare tumor types, variations in treatment response and long-term risk for adverse events can complicate treatment.
If approved, crizotinib would be the first biomarker-driven therapy for this type of lymphoma.
“Despite high survival rates for children with ALK-positive anaplastic large cell lymphoma, many will relapse, requiring novel treatment approaches,” Chris Boshoff, MD, PhD, chief development officer for oncology with Pfizer Global Product Development, said in a company-issued press release. “Given Xalkori’s proven efficacy in ALK-positive lung cancer and activity seen in clinical trials investigating relapsed or refractory ALK- and ROS1-positive anaplastic large cell lymphoma, if approved, Xalkori could represent an important step toward improving outcomes for children with this type of cancer.”
The supplemental new drug application is based on results of two studies.
The phase 1/phase 2 Study ADVL0912 evaluated the clinical activity and tolerability of crizotinib for pediatric patients with relapsed or refractory solid tumors and anaplastic large cell lymphoma. Study A8081013 evaluated crizotinib for children and adults with ALK-positive advanced malignancies other than NSCLC. The study included patients with relapsed or refractory anaplastic large cell lymphoma.
Both studies showed compelling antitumor activity with crizotinib among children and adults, according to Pfizer’s press release.
The FDA is expected to decide on the supplemental application by January.
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