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 lived 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.
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