Gilead's Zydelig Approved By FDA For 3 Blood Cancers
The U.S. Food and Drug Administration (FDA) announced that it has approved Gilead Sciences’ Zydelig for the treatment of three types of blood cancers.
Zydelig (idelalisib) is a first-in-class PI3k delta inhibitor indicated as treatment in combination with rituximab for patients with relapsed chronic lymphocytic leukemia (CLL). The drug is also approved to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and those with relapsed small lymphocytic lymphoma (SLL) who have undergone at least two prior therapies.
“In less than a year, we have seen considerable progress in the availability of treatments for chronic lymphocytic leukemia. 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,” said Richard Pazdur, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
The FDA said Zydelig is the fifth new drug it has designated with breakthrough therapy status as well as the third with this designation to receive approval from the treatment of CLL. The agency has previously approved Genentech’s Gazyva last year for the treatment of CLL. Imbruvica and Arzerra were also approved this year for the same indication.
The company recently received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Zydelig’s Marketing Authorization Application (MAA) in the EU for CLL and FL.
The Leukemia & Lymphoma Society (LLS) lauded the FDA’s approval of Zydelig. The organization said it has contributed to research in B cell malignancies since 1999 and aims to advance cures and access to treatment for patients with blood cancer. Dr. Lee Greenberger, LLS CSO, said, “We have been eagerly awaiting the approval of this therapy as these are patients for whom there are few other good treatment options… Any new advance that brings the potential to help save more lives is good news.”