Zydelig Approved to Treat Three Blood Cancer Subtypes

The U.S. Food and Drug Administration today has approved Zydelig (idelalisib) for the treatment of patients with three types of blood cancers.

First, Zydelig is being granted traditional approval for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). Taken with Rituxan (rituximab), Zydelig is approved for patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions. Zydelig becomes 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 specifically.

The FDA has also granted accelerated approval for Zydelig to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) as well as relapsed small lymphocytic lymphoma (SLL). Zydelig is intended to be used as a thirdline therapy, i.e. 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."

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.

Source: FDA