The US Food and Drug Administration recently approved a treatment for 3 forms of blood cancers.
The US Food and Drug Administration (FDA) recently approved a treatment for 3 forms of blood cancers.
The drug, known as Zydelig (idelalisib) and marketed by Gilead Sciences, is now indicated to treat patients with relapsing chronic lymphocytic leukemia (CLL), though the prescription can also be combined with Rituxan (rituximab) when the latter medication is not enough to help a CLL patient due to other comorbidities, according to an FDA statement.
The statement noted that 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.”
In addition to CLL, the FDA granted Zydelig approval to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL). The FDA said the drug is intended for patients who have had at least 2 prior systemic therapies to treat their symptoms.
“In less than a year, we have seen considerable progress in the availability of treatments for chronic lymphocytic leukemia,” said Richard Padzur, MD, Director of the Office of Hematology and Oncology Products at the FDA’s Center for Drug Evaluation and Research.
During clinical testing for Zydelig’s efficacy in CLL, 220 patients were assigned to receive either the medication combined with Rituxan or placebo combined with Rituxan. According to the FDA, the trial was stopped when patients taking both prescription medications showed no disease progression for 10.7 months, compared to just 5.5 months in the placebo and Rituxan group. A second analysis showed even more significant improvements for patients during their participation in the study.
The results of another study similarly showed that 54% of participants with relapsed FL and 58% of those with SLL experienced objective response rate to Zydelig. However, potential side effects with the treatment include liver toxicity, intestinal perforation, diarrhea, and colon and lung inflammation.
The FDA also approved a Risk Evaluation and Mitigation Strategy (REMS) for Zydelig, which includes a communication plan to inform healthcare professionals of possible risks.
Other drugs that have been approved for the treatment of CLL include Gazyva (obinutuzumab), Imbruvica (ibrutinib), and Arzerra (ofatumumab). According to the FDA, all 3 of those CLL treatments have been approved since November 2013, with Gazyva and Arzerra receiving breakthrough therapy designations.