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ZYDELIG is indicated for relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies
NCCN Guidelines® RECOMMEND idelalisib (ZYDELIG) monotherapy as an option for appropriate patients with relapsed/refractory SLL2*
Key eligibility criteria
ZYDELIG 150 mg PO BID
Therapy maintained until disease progression or unacceptable toxicity
Secondary endpoints included:
Studied in a clinically challenging patient population3,4
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
*Please see the complete version of the NCCN Guidelines® for CLL/SLL (V.4.2019) 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 a 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 that failed to respond or relapsed within 6 months of receiving rituximab and an alkylator.3
¶Bulky disease was defined as the presence of at least 1 lymph node with at least 1 dimension of ≥7 cm.3
#Most common prior regimens: 81% BR, 62% FCR, and 35% R-CHOP.
**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.4,5
BID=twice daily; BR=bendamustine, rituximab; CI=confidence interval; CR=complete response; DoR=duration of response; FCR=fludarabine, cyclophosphamide, rituximab;
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.