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FDA approves Xalkori (Crizotinib) for for the treatment of patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase (ALK)-positive

By: Dr. Christopher Ho on November 21, 2013, 5:18 pm

As part of our recognition of November being Lung Cancer Awareness Month, Dr Omid Shaye, Dr Ashkan Lashkari and I would like to provide late breaking news on the approval crizotinib (Xalkori) in treatment of lung cancer. 

Crizotinib was previously granted accelerated approval in August, 2011 based on durable, objective response rates of 50% and 61% in two single-arm, open-label studies. However another more recent study compared groups of patients whose lung cancer tested POSITIVE for the ALK (anaplastic lymphoma kinase) mutation were treated with traditional chemotherapy versus crizotinib, an oral tyrosine kinase inhibitor in the form of a pill taken twice daily with or without food. 

The trial showed significantly prolonged progression-free survival (PFS or the time it took for the tumor to become larger) for crizotinib treatment compared to chemotherapy. Median PFS was 7.7 months for patients treated with crizotinib versus 3 months for patients treated with chemotherapy. More patients teated with crizotinib were noted to have their tumor shrink versus those with chemotherapy (65% vs. 20%). No difference in overall survival was noted between the two groups in a planned interim analysis, but a likely explanation is that approximately 64% of patients on the chemotherapy treatment group subsequently received crizotinib, which is called a "cross-over". This would be ethically correct as patient as clinical trials are evaluated by the intention to treat which is at the outset of a clinical trial. 

Although not necessarily a surprise to the medical oncology community, it demonstrates the real change in mindset of the treatment of lung cancer. In just 4 years since the presentation of the ground breaking IPASS clinical trial by Dr Tony Mok of the Chinese University of Hong Kong and colleagues showed that lung cancer patients with specific mutations of the tumor, would benefit from the newer tyrosine kinase inhibitors, some  patients are now being treated with these oral medications instead of intravenous chemotherapy. Although these patients are in the minority, we hope that further tumor mutations can be identified and new medications developed. 

Dr Omid Shaye, Dr Ashkan Lashkari and I are board-certified medical oncologists in the San Fernando Valley and Los Angeles Areas, with offices in West Hills and Tarzana. We consider it our responsibility and privilege to keep our patients abreast of the latest in cancer treatments and thinking. Please call us for an appointment at (818) 346 1773