Update: Zydelig to Remain on Market After Trial Deaths, EMA Concludes
July 11, 2016 – Zydelig, which ran into trouble earlier this year after serious adverse events were found in studies, can stay on the market with some new recommendations, according to FiercePharma. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) last Friday wrapped up its review of the cancer drug, confirming that its benefits outweigh its risks. However, Zydelig still carries a risk of series infections, including Pneumocystis jirovecii pneumonia, and patients should receive antibiotics during treatment and for 2 to 6 months after getting Zydelig, the committee said.
What’s the Problem?
March 15, 2016 – The trials were investigating the efficacy of Zydelig in newly diagnosed leukemia and lymphoma patients, according to the U.S. Food & Drug Administration (FDA). The research was part of an effort by Gilead to expand use of Zydelig in combination with a variety of other therapies. Zydelig is currently approved for cancer patients who’ve relapsed after previous treatment. Gilead said it would also halt other trials using Zydelig as a first-line cancer therapy. The European Medicines Agency (EMA) announced that it would conduct a review of the drug on Friday.
What is Zydelig?
Zydelig received FDA approval in July 2014 for the treatment of chronic lymphocytic leukemia (CLL) in combination with Rituxan (generic: rituximab), as well as a solo treatment for 2 types of lymphoma. The stopped trials involved previously untreated patients with the same cancers, and used Zydelig in drug combinations that aren’t yet approved. FDA cautioned that clinicians should avoid prescribing Zydelig to patients with previously untreated CLL.
Black Box Warning
Zydelig carries a black box warning (PDF) regarding the potential for severe, potentially fatal side effects including liver damage, diarrhea, intestinal perforation and pneumonitis (lung inflammation). Other, more moderate side effects of the drug may include:
- Stomach / abdominal pain
- Tiredness / low energy
- High blood sugar (hyperglycemia)
- Low blood sodium (hyponatremia)
Health Canada Issues Warning on Fatal Infection Risk With Zydelig
May 3, 2016 – Decreased survival rates and an increased risk of serious adverse events (mostly infections such as sepsis and pneumonia) were reported in patients treated with Zydelig compared to control groups in clinical trials, according to a warning issued today by Health Canada. The trials evaluated the addition of Zydelig to standard therapies for first line treatment of chronic lymphocytic leukemia (CLL) and early line treatment of relapsed indolent non-Hodgkin’s lymphoma (iNHL). The Canadian Product Monograph for Zydelig (PDF) will be updated to reflect this new information.
EMA Issues New Safety Guidance on Zydelig Following Patient Infections, Death
March 22, 2016 – The European Medicines Agency (EMA) has issued new safety guidance for the use of Zydelig after an increase in adverse events, including deaths, during clinical trials where the drug was combined with other medications. The updated guidelines state that patients treated with Zydelig should receive simultaneous antibiotic therapy to reduce the risk of a lung infection called pneumocystis jirovecii pneumonia (PJP). The agency also recommended monitoring of white blood cell levels and watching for signs of infection, which may include fever, dry cough or wheezing, shortness of breath, rapid breathing, fatigue and chest pain.
Canadian Trials Halted After Zydelig Linked to Deaths
March 17, 2016 – Four trials in Canada exploring the use of “Zydelig in patients with different disease characteristics or with different drug combinations than those for which Zydelig is currently approved for use in Canada” have been stopped after international reports of serious adverse events and death, Health Canada announced today. The agency will also amend 3 other Zydelig studies to ensure patient safety, and conduct a review of the medication.
Can I File a Class Action?
There is currently no class action lawsuit involving injuries allegedly caused by Zydelig side effects. However, our lawyers are reviewing potential individual cases on behalf of people who have been harmed by the drug. If you were injured by Zydelig, or a loved one died after taking it, you may qualify to file a suit against Gilead Sciences Inc. If we determine that you have a legitimate complaint, you may be eligible to receive compensation for medical expenses, lost wages, pain and suffering, funeral costs, and other damages.
Do I Have a Zydelig Lawsuit?
The Class Action 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, you should contact our law firm immediately. You may be entitled to a settlement by filing a lawsuit and we can help.