South Delhi Pharma, New Delhi, India
XALKORI (crizotinib) Capsules. FDA-Approved. To treat non-small cell lung cancer
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XALKORI (crizotinib) is a prescription medicine. XALKORI (crizotinib) is used to treat non-small cell lung cancer (NSCLC).
INDICATIONS AND USAGE
XALKORI is a kinase inhibitor indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. This indication is based on response rate. There are no data available demonstrating improvement in patient reported outcomes or survival with XALKORI.
DOSAGE FORMS & STRENGTHS: XALKORI Capsules: 250 mg and 200 mg.
Manufactured By: Pfizer Inc.
Prescribing Information URL: Click Here
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Crizotinib (trade name Xalkori, among others) is an anti-cancer drug acting as an ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene 1) inhibitor, approved for treatment of some non-small cell lung carcinoma (NSCLC) in the US and some other countries, and undergoing clinical trials testing its safety and efficacy in anaplastic large cell lymphoma, neuroblastoma, and other advanced solid tumors in both adults and children.
On August 26, 2011, the U.S. Food and Drug Administration approved crizotinib (Xalkori) to treat certain late-stage (locally advanced or metastatic) non-small cell lung cancers that express the abnormal anaplastic lymphoma kinase (ALK) gene. Approval required a companion molecular test for the EML4-ALK fusion. In March 2016, the U.S. Food and Drug Administration approved crizotinib in ROS1-positive non-small cell lung cancer.
In October 2012, the European Medicines Agency approved the use of crizotinib (Xalkori) to treat non-small cell lung cancers that express the abnormal anaplastic lymphoma kinase (ALK) gene