April 29 U.S. health regulators on Monday
approved a drug for advanced lung cancer developed by Swiss
drugmaker Novartis AG that is intended to treat
patients with a specific genetic mutation.
The drug, ceritinib, from a new class medicines known as ALK
inhibitors, was approved four months ahead of the expected Food
and Drug Administration decision date.
It will be sold under the brand name Zykadia, the FDA and
Zykadia was approved for use in non-small cell lung cancer
patients who had previously been treated with Pfizer Inc's
Xalkori, another ALK inhibitor.
About four percent of non-small cell lung cancer patients
have the specific mutation of the ALK (anaplastic lymphoma
kinase) protein for which the drug is targeted. They are often
"Today's approval illustrates how a greater understanding of
the underlying molecular pathways of a disease can lead to the
development of specific therapies aimed at these pathways,"
Richard Pazdur, director of cancer products in FDA's Center for
Drug Evaluation and Research, said in a statement.
It had received the FDA's new breakthrough designation,
intended to speed up the review of medicines seen as an advance
over existing therapies or filling a serious unmet need.
(Reporting by Bill Berkrot; Editing by Bernard Orr)