Lung Cancer Dispatch
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New Drug Successfully Treats Crizotinib-Resistant, ALK-Positive Lung Cancer

New Drug Successfully Treats Crizotinib-Resistant, ALK-Positive Lung Cancer | Lung Cancer Dispatch | Scoop.it

"Although the targeted cancer treatment drug crizotinib is very effective in causing rapid regression of a particular form of lung cancer, patients' tumors inevitably become resistant to the drug. Now a new drug called ceritinib appears to be effective against advanced ALK-positive non-small cell lung cancer (NSCLC), both in tumors that have become resistant to crizotinib and in those never treated with the older drug. The results of a phase 1 clinical trial conducted at centers in 11 countries are reported in the March 27 New England Journal of Medicine."


Editor's note: Crizotinib and ceritinib are meant to treat patients whose tumors have mutations in the ALK gene, as detected by molecular testing.

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Medical Xpress  |  Mar 26, 2014

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FDA Fast-Tracks Approval Process for Lung Cancer Drug LDK378

The FDA has designated Novartis’s anticancer drug LDK378 as a "breakthrough therapy," thereby placing it on a faster track for FDA approval. Breakthrough therapy is a status reserved for drugs that treat serious conditions and that have been shown by preliminary studies to provide a substantial improvement over currently available treatments. In addition to the drug being eligible for accelerated approval, a company producing a breakthrough therapy receives more guidance from the FDA throughout drug development. LDK378, which inhibits a protein called ALK, is designed to treat non-small cell lung cancer (NSCLC) with a mutation in the ALK gene. It may be effective in patients with ALK-mutant NSCLC who have become resistant to the ALK inhibitor crizotinib (Xalkori).

Cancer Commons's insight:

Reuters | Mar 15, 2013

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Raja Mudad's curator insight, March 18, 2013 1:09 PM

More drugs approved for Lung cancer. This one will be for patients wit ALK positive mutation who have failed Xalkori.

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New Lung Cancer Drug LDK378 Appears Effective

In an ongoing phase I clinical trial, the new lung cancer drug LDK378 showed signs of effectiveness in advanced non-small cell lung cancer (NSCLC) with mutations in the ALK gene. Sixty percent of the patients treated with the highest dose of LDK378, which blocks ALK, benefited from the drug. These effects were seen both in patients who had never been treated with the ALK inhibitor crizotinib (Xalkori) before and patients who had become resistant to Xalkori. LDK378 was declared a Breakthrough Therapy by the FDA in March, a designation intended to expedite the development and approval process of treatments for life-threatening conditions. Novartis, which produces LDK378, is initiating two phase II clinical trials (one examining patients who were previously treated with chemotherapy and Xalkori, the other patients with no history of Xalkori treatment) and planning a forthcoming phase III trial.

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Yahoo! Finance | June 3, 2013

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