July 23 The U.S. Food and Drug Administration
has approved Gilead Inc's drug Zydelig to treat three
types of blood cancer, the agency said on Wednesday.
The FDA approved it for use in combination with Roche AG's
Rituxan for patients with relapsed chronic lymphocytic
The agency gave the drug so-called accelerated approval for
patients with relapsed follicular B-cell non-Hodgkin lymphoma
and relapsed small lymphocytic lymphoma who have received at
least two prior therapies.
Under the accelerated approval program, companies must
conduct additional trials to confirm that the drug's apparent
benefit is real.
The drug will carry a boxed warning highlighting the risk of
serious and potentially fatal toxicities, including toxicity,
diarrhea, inflammation of the colon and lung and perforation of
(Reporting by Toni Clarke in Washington; Editing by Susan