Zydelig

2022: Partial withdrawal of the drug due to fatal side effects

On January 14, 2022, an American biopharmaceutical company Gilead Sciences notified the regulator health care USA of its decision to voluntarily abandon the use of its drug Zydelig for the treatment of two types, cancer namely follicular lymphoma and small lymphocytic. leukemias

Previously, the US Food and Drug Administration (FDA) issued an accelerated approval for the drug to treat recurrent follicular B-cell non-Hodgkin lymphoma and recurrent small lymphocytic leukemia along with recurrent chronic lymphocytic leukemia. However, this resolution was accompanied by a warning about the risk of serious and potentially fatal toxic effects. In 2016, European and US regulators began testing the safety of the drug due to concerns about serious adverse events, including deaths.

Gilead withdraws indications of cancer drug Zydelig due to fatal side effects

Gilead Sciences said the drug Zydelig will continue to be marketed in the US market for the treatment of small lymphocytic leukemia, a type of cancer that begins with specialized immune cells called B lymphocytes. The drug will be available for the treatment of follicular lymphoma and small lymphocytic leukemia in the European Union, UK, Canada, Australia, New Zealand and Switzerland.

The Zydelig product label contains all warnings regarding the risks of fatal and serious toxicity and other side effects: harm to the liver, severe diarrhea, colitis, pneumonitis and intestinal perforation. The packaging of the drug also includes the provision of important safety information, including contraindications, warnings and precautions.

The most frequent adverse reactions with a frequency of more than 20% in patients treated with or without Zydelig with rituximab were diarrhea, fever, fatigue, nausea, cough, abdominal pain, chills, and rash. The most frequent deviations of laboratory indicators with a frequency of more than 30% in patients, in clinical studies were neutropenia, hypertriglyceridemia, hyperglycemia and an increase in de Ritis coefficient, an endogenous enzyme from the transferase group, a subgroup of aminotransferases widely used in medical practice for laboratory diagnosis of liver damage. ^[1]

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