* LDK378 treats non-small cell lung cancer
* Compound seen as potential future blockbuster
* Novartis sees first regulatory filing in early 2014
ZURICH, March 15 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
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)