Crizotinib, CAS number 877399-52-5, is also known as the brand Xalkori. Xalkori, manufactured Pfizer, was approved on August 26, 2011 by the FDA for metastatic non-small cell lung cancer. Crizotinib is ideal for patients who have a certain type of chromosome translocation, specifically one that affects the anaplastic lymphoma kinase, or ALK gene, which causes cancer growth and development. While three to five percent of patients with non-small cell lung cancer harbor the ALK translocation, this figure may not account for all patients with the translocation. In a recent study Dr. Mark Kris, of Memorial Sloan-Kettering Cancer Center, announced that eight percent of patients with the adenocarcinoma type of NSCLC may also have the chromosome translocation. This information translates into as many as 16,000 patients with non-small cell lung cancer and adenocarcinoma per year who may be candidates for the Crizotinib.
By blocking the proteins produced by the ALK gene, Crizotinib is efficacious and novel, as it is administered to patients as two capsules daily, in 250 or 200 milligram strength. Capsules must be swallowed whole, and Crizotinib can be taken with or without food. Common adverse effects for patients in clinical trials included nausea, diarrhea, vomiting, edema, constipation and visual disturbances. Abdominal pain, fatigue and dizziness were also reported by patients. Caution should be taken by providers concerning the risk of hepatoxicity and Pneumonitis in certain patients.
Results from studies indicate a favorable and formidable response from patients who received Crizotinib, and the FDA endorsed an accelerated approval of Crizotinib in 2011. In a phase 2 study of Crizotinib, which was conducted by Yung-Jue Bang, MD, PhD, from Seoul National University College of Medicine in Korea, more than 90 percent of patients who received 250 milligram doses of Crizotinib twice daily showed tumor shrinkage. The patients, all of whom possessed the ALK fusion gene had also progressed on roughly three previous chemotherapy regimens. In addition, the patients were given a 72 percent probability of being progression-free at 6 months. These results are astounding for this hard to treat patient population, and researchers are continuing to study the benefits of using Crizotinib, not only for specific cases of non-small cell lung cancer, but also for treating other cancers, such as skin and blood cancer. LGM Pharma provides the API Crizotinib for research and development purposes, and offers client assistance throughout the entire R&D process.
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