Cedars-Sinai Medical Center

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A BI-WEEKLY PUBLICATION FROM THE CEDARS-SINAI CHIEF OF STAFF March 25, 2016 | Archived Issues

FDA Warns About Zydelig

Pharmacy Focus

The U.S. Food and Drug Administration is alerting healthcare professionals about reports of an increased rate of adverse events, including deaths, in clinical trials with the cancer medicine Zydelig in combination with other cancer medicines.

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Meetings and Events


Grand Rounds

Click here to view upcoming grand rounds.


Upcoming CME Conferences

Click below to view a complete list of all scheduled Continuing Medical Education conferences.

CME Newsletter - March 2016 (PDF)  


Milestones

Morton W. Klein, MD, has died.

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Share Your News

Won any awards or had an article accepted for publication? Share your news about professional achievements and other items of interest.

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FDA Warns About Zydelig

Pharmacy Focus

The U.S. Food and Drug Administration is alerting healthcare professionals about reports of an increased rate of adverse events, including deaths, in clinical trials with the cancer medicine Zydelig in combination with other cancer medicines.

The drug's maker, Gilead Sciences Inc., has confirmed that it is stopping six clinical trials in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and indolent non-Hodgkin lymphomas.

Healthcare professionals should be aware that Zydelig (idelalisib) is not approved for previously untreated chronic lymphocytic leukemia.

Zydelig is currently approved by the FDA for the treatment of:

  • Relapsed chronic lymphocytic leukemia, in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other comorbidities
  • Relapsed follicular B-cell non-Hodgkin lymphoma in patients who have received at least two prior systemic therapies
  • Relapsed small lymphocytic lymphoma in patients who have received at least two prior systemic therapies

The FDA has more information.