Drug against specific blood cancers approved by the US FDA
23 Jul 2014
The US FDA approved idealisib against relapsed chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma (NHL) and relapsed small lymphocytic lymphoma.
The drug's trade name is "Zydelig".
In particular the FDA approved
- the use of Zydelig in combination with another drug, Rituxan (manufactured by Roche), for patients with relapsed chronic lymphocytic leukemia (CLL)
- the use of Zydelig under a so-called accelerated approval program for relapsed follicular B-cell non-Hodgkin lymphoma (NHL) and relapsed small lymphocytic lymphoma, when patients have received at least two prior therapies.
For drugs given accelerated approval, companies must conduct additional trials to confirm that the drug's apparent benefit is real.
Zydelig will carry a boxed warning highlighting the risk of serious and potentially fatal toxicities, including liver toxicity, diarrhea, inflammation of the colon and lung, and perforation of the intestine.
It will be marketed using a special risk management program.