Key FDA designation given to Novartis’ lung cancer drug

Hannah Blake


Novartis’ non-small lung cancer drug has been designated a ‘breakthrough therapy’ by the US Food and Drug Administration (FDA). Novartis’ compound LDK378 is designed to treat anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer.

The FDA started the ‘breakthrough therapy’ program in 2012 as a way to speed up the review process of drugs that treat life-threatening conditions, if the therapy has already demonstrated efficacy.

“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.”

Alessandro Riva, Novartis head of oncology development.

Novartis’ LDK378 will now receive fast-track development and review from the FDA. Two phase 2 clinical trials are currently taking place and the Swiss pharma company plans to launch several phase 3 trials later on this year.

Novartis expects to file its first regulatory filing for LDK738 by early 2014.


Related news:

Novartis lung cancer drug gets key FDA designation (Bloomberg Businessweek)

FDA seeks to fast track Novartis lung cancer drug (Reuters)

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