publication date: Jul. 31, 2014
Zydelig Tablets Approved for Three Blood Cancers
FDA approved Zydelig (idelalisib) tablets for the treatment of three B-cell blood cancers.
Zydelig is indicated for patients with relapsed chronic lymphocytic leukemia in combination with rituximab for whom rituximab alone would be considered appropriate therapy; as monotherapy for patients with relapsed follicular B-cell non-Hodgkin lymphoma; and for small lymphocytic lymphoma patients who have received at least two prior systemic therapies.
Accelerated approval was granted for the follicular B-cell and small lymphocytic lymphoma indications based on overall response rate. Zydelig is a first-in-class inhibitor of PI3K delta, a protein that is over-expressed in many B-cell malignancies and plays a role in the viability, proliferation and migration of these cancer cells.
Approval in CLL is supported primarily by data from a randomized, placebo-controlled phase III trial of Zydelig plus rituximab in 220 patients with relapsed CLL who were not able to tolerate standard chemotherapy.
The study was stopped early in October 2013 by an independent data monitoring committee due to a highly statistically significant benefit in progression-free survival in the Zydelig arm as compared to those receiving rituximab alone [HR=0.18 (95% CI: 0.10, 0.32), p<0.0001].
Median PFS was not reached in the Zydelig plus rituximab arm (95% CI: 10.7 months, NR) and was 5.5 months in the placebo plus rituximab arm (95% CI: 3.8, 7.1). FDA granted Zydelig a Breakthrough Therapy designation for relapsed CLL.
Zydelig’s accelerated approval in FL and SLL is supported by data from a single-arm phase II study of Zydelig monotherapy in patients refractory to rituximab and alkylating-agent-containing chemotherapy (FL: n=72; SLL: n=26).
Continue reading CCL July – FDA News
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