Earlier this afternoon the FDA announced the approval of Zydelig (idelalisib) for patients with relapsed chronic lymphocytic leukemia (CLL). Accelerated approval was also granted for the use of Zydelig in patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL). According to the FDA press release:
“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.”
Commenting on this welcomed development Dr. Richard Furman said, “We are very excited to have idelalisib to add to our armentarium of agents that are now available for use and would like to thank all of the patients and their families who made this possible by participating in the clinical trials.” Look to this blog and our clinical trials page for further developments regarding the use of Zydelig in the treatment of CLL, FL, & SLL patients.