FDA Approves Gilead Sciences’ Cancer Drug Zydelig
The US Food and Drug Administration has approved Gilead Sciences’ 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.
The FDA approved Roche’s Gazyva (obinutuzumab) in November 2013, Janssen Biotech/Pharmacyclics’ Imbruvica (ibrutinib) in February 2014, and a new use for GlaxoSmithKline’s 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. 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.