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ZYDELIG is indicated for relapsed follicular lymphoma in patients who have received at least two prior systemic therapies
ZYDELIG is the most prescribed PI3K inhibitor*
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) RECOMMEND idelalisib (ZYDELIG) monotherapy as an option for appropriate patients with relapsed/refractory follicular lymphoma2†
Key eligibility criteria
ZYDELIG 150 mg PO BID
Follicular lymphoma: n=72
Therapy maintained until disease progression or unacceptable toxicity
Secondary endpoints included:
Studied in a clinically challenging patient population3,5
Median age (range), years
Prior therapies,** median (range)
To rituximab and an alkylator
High disease burden
Ann Arbor stage III/IV
Baseline cytopenias,‡‡ any grade
*IntrinsiQ, May 2015 - November 2018, IMS XPO and IMS DDD data, October 2018-March 2019.
†Please see the complete version of the NCCN Guidelines® for B-cell Lymphomas (V.3.2019) available on NCCN.org for specific recommendations.
‡The study population included patients with follicular lymphoma, small lymphocytic lymphoma, marginal-zone lymphoma, or lymphoplasmacytic lymphoma with or without Waldenström macroglobulinemia.3
§ORR was defined as the proportion of patients who achieved CR or PR. Responses were assessed by an IRC.3
||DoR was measured from the onset of response to disease progression.3
¶Double refractory defined as patients who failed to respond or relapsed within 6 months of receiving rituximab and an alkylator.3
#Among follicular lymphoma patients in the study (n=72), 37 of the 46 who received first-line chemoimmunotherapy had early disease progression.5
**Most common prior regimens: 50% BR, 49% R-CHOP, and 28% R-CVP.
††Bulky disease was defined as the presence of at least 1 lymph node with at least 1 dimension of ≥7 cm.3
‡‡Cytopenias were defined as blood cell counts below the lower limit of normal (<LLN). Anemia was defined as a disorder characterized by a reduction in the amount of hemoglobin in 100 mL of blood. Neutropenia was defined as a finding based on laboratory tests that indicate a decrease in number of neutrophils in the blood specimen. Thrombocytopenia was defined as a finding based on laboratory test results that indicate a decrease in number of platelets in a blood specimen.4,8
ANC=absolute neutrophil count; BID=twice daily; BR=bendamustine, rituximab; CI=confidence interval; CR=complete response; DoR=duration of response; FLIPI=Follicular Lymphoma International Prognostic Index; IRC=independent review committee; LLN=lower limit of normal; NCCN=National Comprehensive Cancer Network; ORR=overall response rate; PLT=platelet count; PO=orally; PR=partial response; PS=performance status; R-CHOP=rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone; R-CVP=rituximab, cyclophosphamide, vincristine sulfate, prednisone; TTR=time to response.