The US FDA gave the drug an accelerated approval to treat relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic leukemia along with relapsed Chronic Lymphocytic Leukemia (CLL)
Gilead Sciences Inc recently notified the US health regulator of its decision to voluntarily withdraw the use of its drug Zydelig for two types of cancer – follicular lymphoma and small lymphocytic leukemia.
The US Food and Drug Administration (FDA) gave the drug an accelerated approval to treat relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic leukemia, along with relapsed Chronic Lymphocytic Leukemia (CLL).
The approval, however, came with a boxed warning highlighting the risk of serious and potentially fatal toxicities.
Two years later, a regulatory review of the drug’s safety was launched by the European and US regulators due to concerns over serious adverse events, including deaths.
Gilead said Zydelig will continue to be sold in the US market for treating CLL. It will be available to treat CLL and FL in the European Union, the UK, Canada, Australia, New Zealand and Switzerland.
About Gilead Science
Gilead Sciences, Inc. , is an American biopharmaceutical company headquartered in Foster City, California, that focuses on researching and developing antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi. Gilead is a member of the NASDAQ Biotechnology Index and the S&P 500.
The company has been the subject of significant controversy over its business practices, including extremely high pricing of drugs such as Sovaldi and Truvada in the United States relative to production cost and cost in the developing world.