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Zydelig (idelalisib) is a kinase inhibitor approved in 2014 for 3 oncology indications.
Zydelig (idelalisib) is a kinase inhibitor initially approved in 2014 for 3 oncology indications. The medication was approved in combination with rituximab for patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered inappropriate therapy due to other comorbidities; for relapsed follicular B-cell non-Hodgkin lymphoma in patients who have received at least 2 prior systemic therapies; and for patients who have relapsed small lymphocytic lymphoma in patients who have received at least 2 prior systemic therapies.
For relapsed CLL, the pivotal trial’s primary end point was progression-free survival (PFS), as assessed by an independent review committee. The trial was stopped for efficacy following the first prespecified interim analysis. The results of a second interim analysis showed a statistically significant improvement for idelalisib plus rituximab over placebo plus rituximab for the primary end point of PFS.