Gilead Sciences has stopped six clinical trials using its drug idelalisib (Zydelig) in combination with other cancer drugs on account of a higher rate of serious adverse events, including death, the US Food and Drug Administration (FDA) said today.
The announcement follows the recent decision by European Union (EU) regulators to review idelalisib in response to an increased rate of serious adverse events such as death in three clinical trials that combined the Gilead Sciences drug with other cancer drugs.
Idelalisib is approved in the United States to treat relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab; relapsed follicular B-cell non-Hodgkin lymphoma, which is classified as indolent; and relapsed small lymphocytic lymphoma. The agency cautioned today that clinicians should not prescribe the drug for patients with previously untreated CLL.
The six clinical trials in question involved small lymphocytic lymphoma, CLL, and indolent non-Hodgkin lymphoma, the FDA said. The latter two cancers figured into the three trials scrutinized by EU regulators.
The FDA said it is reviewing the findings of the six clinical trials stopped by Gilead Sciences.
More information about today's FDA announcement is available on the agency website.
The announcement follows the recent decision by European Union (EU) regulators to review idelalisib in response to an increased rate of serious adverse events such as death in three clinical trials that combined the Gilead Sciences drug with other cancer drugs.
Idelalisib is approved in the United States to treat relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab; relapsed follicular B-cell non-Hodgkin lymphoma, which is classified as indolent; and relapsed small lymphocytic lymphoma. The agency cautioned today that clinicians should not prescribe the drug for patients with previously untreated CLL.
The six clinical trials in question involved small lymphocytic lymphoma, CLL, and indolent non-Hodgkin lymphoma, the FDA said. The latter two cancers figured into the three trials scrutinized by EU regulators.
The FDA said it is reviewing the findings of the six clinical trials stopped by Gilead Sciences.
More information about today's FDA announcement is available on the agency website.
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