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FDA seeks to fast track Novartis lung cancer drug
March 15, 2013 / 7:27 AM / in 5 years

FDA seeks to fast track Novartis lung cancer drug

* LDK378 treats non-small cell lung cancer

* Compound seen as potential future blockbuster

* Novartis sees first regulatory filing in early 2014

ZURICH, March 15 (Reuters) - The U.S. Food and Drug Administration has designated a compound developed by Novartis AG to treat a type of non-small cell lung cancer for fast-track development and review, the Swiss drugmaker said on Friday.

Novartis said the FDA had given “breakthrough therapy” designation to its LDK378 compound, a process aimed at speeding up the review of drugs that treat life-threatening conditions if the therapy has demonstrated efficacy.

LDK378 - seen as a potential future blockbuster - is designed to treat anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC). Sufferers tend to be non-smokers and younger than other lung cancer patients.

Novartis said two Phase II trials were under way and it planned to launch several Phase III trials later this year with first regulatory filing expected by early next year.

“This breakthrough therapy designation will allow us to collaborate more closely with the FDA and potentially to expedite the availability of an important new treatment option for patients with ALK+ NSCLC,” said Alessandro Riva, Novartis head of oncology development. (Reporting by Emma Thomasson, editing by William Hardy)

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