publication date: Mar. 18, 2016

Gilead Halts 6 Zydelig Trials as FDA, EMA Warn of Deaths From Respiratory Infections 

 

FDA is alerting health care professionals about reports of an increased rate of adverse events, including deaths, in clinical trials with the cancer medicine Zydelig (idelalisib) in combination with other cancer medicines.

Gilead Sciences Inc. stopped six clinical trials involving Zydelig, in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and indolent non-Hodgkin lymphomas. The FDA said it is reviewing the findings of the clinical trials and will communicate new information as necessary. Health care professionals should be aware that Zydelig is not approved for previously untreated chronic lymphocytic leukemia, the agency said.

The FDA is urging health care professionals and patients to report adverse events involving Zydelig to the FDA MedWatch program.

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee issued provisional advice for doctors and patients, while the medicine is being reviewed, to ensure that it continues to be used as safely as possible. Zydelig is currently authorized in the EU to treat chronic lymphocytic leukemia and follicular lymphoma.

The committee recommends that all patients treated with Zydelig should receive antibiotics to prevent a particular type of lung infection, Pneumocystisjirovecii pneumonia. Patients should also be monitored for infection and have regular blood tests for white cell counts because low counts can increase their risk of infection. Zydelig should not be started in patients with a generalized infection. It should also not be started in previously untreated patients with CLL whose cancer cells have certain genetic mutations (17p deletion … Continue reading 42-11 Gilead Halts 6 Zydelig Trials as FDA, EMA Warn of Deaths From Respiratory Infections

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