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C.L. Mike Schmidt Published by C.L. Mike Schmidt

Gilead Sciences Inc. is halting 6 clinical trials involving the cancer medication Zydelig (generic: idelalisib) after some patients died or suffered serious side effects while taking it, according to the U.S. Food & Drug Administration (FDA) [1].

Free Confidential Lawsuit Evaluation: If you or a loved one was injured by Zydelig side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

Update: PRAC Concludes Zydelig Safety Review, Issues Recommendations for Use

July 7, 2016 – The European Medicine Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) [2] has completed its review of Zydelig (idelalisib), confirming a risk of serious infections with the drug, including Pneumocystis jirovecii pneumonia. The committee has updated recommendations to manage this risk. The review was initiated after an increased rate of serious adverse events associated with infections such as pneumonia was seen in 3 clinical trials among patients treated with either Zydelig or a placebo drug.

What’s the problem?

March 15, 2016 – FDA’s warning followed similar news from the European Medicines Agency (EMA), where last week a number of deaths attributable to infections were reported in 3 clinical trials involving Zydelig. All trials in question were looking at the use of Zydelig in combination with other cancer medications designed to treat chronic lymphocytic leukemia, small lymphocytic lymphoma and indolent non-Hodgkin lymphomas. Details on the number of deaths were not made available, and Gilead has not issued a statement.

FDA is “aware of and is looking into reports of deaths,” said agency spokeswoman Angela Stark. “The safety of patients is a top priority and the FDA will communicate new safety-related information on Zydelig as it becomes available.”

In a statement Friday, EMA said it would review trial data “to assess whether the findings have any consequences for the authorized uses of Zydelig.” In the meantime, patients treated with the drug should be “carefully monitored” for signs of infection, according to the agency. It is unclear which other drugs were being combined with Zydelig in the trials, but the EMA said at least one trial involved the use of an unapproved medication.

What is Zydelig?

Zydelig is a first-in-class kinase inhibitor medication that interferes with the growth and spread of cancer cells in the body. The drug is used together with Rituxan (generic: rituximab) for the treatment of chronic lymphocytic leukemia that has relapsed. In its 2014 annual report, Gilead referred to Zydelig as “a new therapy for patient populations with few other options.”

Pre-approval studies showed significant benefits with Zydelig, according to the FDA. One trial involving leukemia patients treated with the drug in combination with Rituxan found a potential for nearly 11 months of survival without disease progression, compared with 5.5 months for patients who took Rituxan with a placebo.

Zydelig Side Effects

Zydelig carries a black box warning (PDF) regarding serious and potentially fatal side effects related to:

  • Liver damage
  • Diarrhea
  • Intestinal perforation
  • Pneumonitis (lung inflammation)

Other, less severe side effects of Zydelig may include:

  • Nausea
  • Vomiting
  • Cough
  • Stomach / abdominal pain
  • Fever
  • Infection
  • Chills
  • Rash
  • Tiredness / low energy
  • High blood sugar (hyperglycemia)
  • Low blood sodium (hyponatremia)

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Health Canada Issues Safety Warning on Zydelig Side Effects

May 3, 2016 – Health Canada has issued a safety warning [3] about an increased risk of adverse events and decreased risk of overall survival associated with Zydelig. The problems were observed in Phase III studies investigating Zydelig for first-line treatment of chronic lymphocytic leukemia (CLL) and early lines of relapsed indolent non-Hodgkin’s lymphoma (iNHL). Most of the adverse events linked to the drug were infections such as sepsis and pneumonia.

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EMA Issues Safety Guidance on Zydelig Following Patient Deaths

March 22, 2016 – The European Medicines Agency (EMA) has issued updated safety guidance [4] for the use of Zydelig after it was linked to adverse events, including deaths, during clinical trials. According to the new guidelines, patients are to receive antibiotics while undergoing treatment with Zydelig in order to prevent a lung infection called pneumocystis jirovecii pneumonia (PJP) [5]. The agency also recommended that physicians monitor white blood cell levels for signs of PJP infection.

Health Canada Ends Zydelig Trials Following Deaths

March 18, 2016 – Four clinical trials in Canada involving Zydelig in combination with other cancer treatment medications have been halted following reports of “an increased rate of serious adverse events, including deaths,” according to a statement by Health Canada [6]. In addition to the 4 suspended trials, another 3 studies will be amended by instituting protective measures to ensure patient safety. Health Canada also said it would conduct a review of Zydelig.

Do I Have a Zydelig Lawsuit?

The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zydelig lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

Free Confidential Case Evaluation: Again, if you were injured by Zydelig, or a loved one died after taking the medication, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and our lawyers can help.

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