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FDA backs NSCLC drug development
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RegulatorySwitzerland

FDA backs NSCLC drug development

18.03.2013 - After having shown an 80% response rate in lung cancer patients, the US-FDA has granted breakthrough status to Novartis’ Phase I ALK blocker LDK378.

The novel „breakthrough status“ opens up the possibility to Novartis to conduct only one instead further two clinical study phases before bringing the compound to the market. Novartis, which had already begun recruiting patients for several Phase II studies with LDK378 to improve treatment for patients with metastatic non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) mutations is slated to start phase III testing this year. The company, which started clinical testing of LDK378 in 2011, said, it plans to file for market authorisation at the beginning of 2014. 

The LDK378 treatment will be made available to a subgroup of patients who did not respond sufficiently to crizotinib treatment and who suffers from limited treatment options. In a Phase I trial Novartis’  "breakthrough drug" showed 80% response rate in 88 patients with advanced ALK-positive NSCLC, which makes about 8% of all NSCLC cases.  LDK378 is a highly selective inhibitor of an important cancer target, anaplastic lymphoma kinase (ALK). Because it is an investigational compound, the safety and efficacy profile of LDK378 has not yet been established. 

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