Product Dossier
ZYDELIG
Product Dossier for ZYDELIG (idelalisib, Gilead Sciences). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Gilead Sciences
- Active ingredient: idelalisib
- Therapeutic area: Oncology
- Same area: TALZENNA
- Same area: ZARZIO
What it is
Zydelig is a phosphoinositide 3-kinase (PI3K) inhibitor indicated as monotherapy for the treatment of patients with refractory follicular lymphoma, and in combination with rituximab for the treatment of patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
Approved indications
— Refractory follicular lymphoma in patients who have received at least 2 prior systemic therapies, as monotherapy. — Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) in combination with rituximab for patients for whom chemo-immunotherapy is not considered suitable, either upon relapse after at least one prior therapy or as first-line treatment in the presence of 17p deletion or TP53 mutation.
PBS listing
Zydelig is listed on the PBS in 100 mg and 150 mg tablet strengths. Both strengths are subject to authority required restrictions, with an ex-manufacturer price of A$4956.86 per listing.
Regulatory history
Zydelig was first registered on the ARTG on 9 February 2015, available in 100 mg and 150 mg tablet formulations. The TGA approved Zydelig on 30 January 2015 for the treatment of refractory follicular lymphoma and, in combination with rituximab, for chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). In July 2016, the PBAC recommended listing of idelalisib in combination with rituximab for use in patients with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma. The PBAC acknowledged progression free survival and overall survival advantage, but noted that significant adverse events remained a concern. Also in July 2016, the PBAC recommended an authority required listing of idelalisib as monotherapy for relapsed or refractory follicular B-cell non-Hodgkin's lymphoma that has progressed despite prior treatment with rituximab and an alkylating agent, noting high unmet clinical need and considering idelalisib a clinically effective last-line treatment option. In August 2016, the PBAC recommended listing for relapsed or refractory CLL or SLL, requiring evidence of a 17p deletion and potentially TP53 mutation if testing available. In December 2021, restrictions were updated to allow 17p deletion to be detected by any MBS-listed test, effective 1 January 2022.