Idelalisib (Zydelig) for three types of blood cancers approved

July 23, 2014 – The U.S. Food and Drug Administration today approved Zydelig (idelalisib) to treat patients with three types of blood cancers.

Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has returned (relapsed). Used in combination with Rituxan (rituximab), Zydelig is to be used in patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions (co-morbidities). Zydelig is the fifth new drug with breakthrough therapy designation to be approved by the FDA and the third drug with this designation approved to treat CLL.

The FDA is also granting Zydelig accelerated approval to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL), another type of non-Hodgkin lymphoma. Zydelig is intended to be used in patients who have received at least two prior systemic therapies.

“In less than a year, we have seen considerable progress in the availability of treatments for chronic lymphocytic leukemia,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Zydelig’s approval to treat CLL reflects the promise of the breakthrough therapy designation program and represents the FDA’s commitment to working cooperatively with companies to expedite a drug’s development, review and approval.”

The FDA approved Gazyva (obinutuzumab) in November 2013, Imbruvica (ibrutinib) in February 2014 and a new use for Arzerra (ofatumumab) in April 2014 to treat CLL. Both Gazyva and Arzerra also received breakthrough therapy designation for this indication. Like the other two drugs, Zydelig was also granted orphan product designation because it is intended to treat a rare disease.

Zydelig’s safety and effectiveness to treat relapsed CLL were established in a clinical trial of 220 participants who were randomly assigned to receive Zydelig and Rituxan or placebo and Rituxan. The trial was stopped for efficacy following the first pre-specified interim analysis point, which showed participants treated with Zydelig and Rituxan had the possibility of living at least 10.7 months without their disease progressing (progression-free survival) compared to about 5.5 months for participants treated with placebo and Rituxan. Results from a second interim analysis continued to show a statistically significant improvement for Zydelig and Rituxan over placebo and Rituxan.

Zydelig’s safety and effectiveness to treat relapsed FL and relapsed SLL were established in a clinical trial with 123 participants with slow-growing (indolent) non-Hodgkin lymphomas. All participants were treated with Zydelig and were evaluated for complete or partial disappearance of their cancer after treatment (objective response rate, or ORR). Results showed 54 percent of participants with relapsed FL and 58 percent of participants with SLL experienced ORR.

The FDA is approving Zydelig to treat FL and SLL under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials.

Zydelig carries a Boxed Warning alerting patients and health care professionals of fatal and serious toxicities including liver toxicity, diarrhea and colon inflammation (colitis), lung inflammation (pneumonitis) and intestinal perforation that can occur in Zydelig-treated patients. Zydelig is also being approved with a Risk Evaluation and Mitigation Strategy (REMS) comprised of a communication plan to ensure healthcare providers who are likely to prescribe Zydelig are fully informed about these risks.

Common side effects include diarrhea, fever (pyrexia), fatigue, nausea, cough, pneumonia, abdominal pain, chills and rash. Common laboratory abnormalities include decreased levels of white blood cells (neutropenia), high levels of triglycerides in the blood (hypertriglyceridemia), high blood sugar (hyperglycemia) and elevated levels of liver enzymes.

Zydelig is marketed by Foster City, California-based Gilead Sciences. Rituxan and Gazyva are marketed by Genentech, a member of the Roche Group, based in South San Francisco, California. Imbruvica is co-marketed by Sunnyvale, California-based Pharmacyclics and Raritan, New Jersey-based Janssen Biotech, Inc. Arzerra is marketed by Research Triangle Park, North Carolina-based GlaxoSmithKline.

 

Tags: , , , , , , , , ,
About the Author
Joseph Gut - thasso Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

Your opinion

Comment

No comments yet

thasso: conditions

thasso: newest tweets

thasso: recent comments

View my Flipboard Magazine.

thasso: categories

thasso: archives

thasso: simple chat

You must be a registered user to participate in this chat.

  • The genetics of side-effects November 25, 2020
    Henk-Jan Guchelaar knows all too well the serious problems that the side-effects of medication can cause. As a professor of clinical pharmacy at the University of Leiden in the Netherlands, he has spent the last two decades trying to get the link between medicine and our genes recognised more widely.
  • Gene donors at high risk for cancer received feedback November 25, 2020
    Researchers at the Estonian Genome Center at the University of Tartu studied how people at high risk for breast, ovarian or prostate cancer responded to the feedback of genetic findings. Gene donors who chose to receive results appreciated being contacted and considered the information provided to be valuable. Authors find that knowing more about people's […]
  • Researchers reveal how genetic variations are linked to COVID-19 disease severity November 25, 2020
    Even as tens of thousands of Americans test positive for COVID-19 each day, physicians still aren't sure why some people experience mild to no symptoms while others become critically ill. New research led by Robert E. Gerszten, MD, Chief of the Division of Cardiovascular Medicine at Beth Israel Deaconess Medical Center (BIDMC) sheds new light […]
  • Study identifies new functions in the gene that causes Machado-Joseph disease November 25, 2020
    Ataxia is a minority disease with genetic origins, known for its neuromuscular alterations due to the selective loss of neurons in the cerebellum, the organ of our nervous systems which controls movement and balance. UB researchers have identified new functions in the ataxin 3 gene (ATXN3)–which causes Machado-Joseph disease, the most common type of ataxia– […]
  • BICRA gene provides answers to patients, doctors and scientists November 23, 2020
    Physicians and scientists are constantly on the lookout for new disease genes that can help them understand why patients have undiagnosed medical problems. Often the first clues come from genetic testing that reveals a change or mutation in a gene that they see in a child but not their parents. This is exactly what led […]
  • Understanding traditional Chinese medicine can help protect species November 26, 2020
    Demystifying traditional Chinese medicine for conservationists could be the key to better protecting endangered species like pangolins, tigers and rhino, according to University of Queensland-led researchers. UQ PhD candidate Hubert Cheung said efforts to shift entrenched values and beliefs about Chinese medicine are not achieving conservation gains in the short term.
  • Satellite images confirm uneven impact of climate change November 26, 2020
    University of Copenhagen researchers have been following vegetation trends across the planet's driest areas using satellite imagery from recent decades. They have identified a troubling trend: Too little vegetation is sprouting up from rainwater in developing nations, whereas things are headed in the opposite direction in wealthier ones. As a result, the future could see […]
  • Survival protein may prevent collateral damage during cancer therapy November 25, 2020
    Australian researchers have identified a protein that could protect the kidneys from 'bystander' damage caused by cancer therapies. The 'cell survival protein', called BCL-XL, was required in laboratory models to keep kidney cells alive and functioning during exposure to chemotherapy or radiotherapy. Kidney damage is a common side effect of these widely used cancer therapies, […]
  • New discovery by SMART allows early detection of shade avoidance syndrome in plants November 25, 2020
    Researchers from Singapore-MIT Alliance for Research and Technology (SMART) have developed a tool that allows early detection of shade avoidance syndrome (SAS) in plants using Raman spectroscopy in significantly less time compared to conventional methods. The discovery can help farmers better monitor plant health and lead to improved crop yield.
  • Psychological factors contributing to language learning November 25, 2020
    Motivation for language learning is a system of cognitive, emotional, and personality-related characteristics.
Top