Efficacy and safety of REVLIMID were evaluated in pretreated patients with
advanced disease1
• In a multicenter, single-arm, single-agent, open-label study (N=134)a
•
92% (124/134) of patients had stage III-IV disease; 78% (105/134) of patients had received ≥3 prior systemic therapies;
60% (81/134) of patients were refractory to prior bortezomib; 55% (74/134) of patients were refractory to last prior therapy
• Refractory disease was defined as without any response of PR or better during treatment with bortezomib or a
bortezomib-containing regimen; relapsed disease was defined as progression within one year after treatment with
bortezomib or a bortezomib-containing regimenb
• Patients received REVLIMID 25 mg orally, once daily for 21 days every 28 days. Treatment was continued until
disease progression, unacceptable toxicity, or withdrawal of consent
a
134 patients evaluated for safety; 133 patients evaluated for efficacy.1
b Had received prior treatment with anthracycline or mitoxantrone, cyclophosphamide, rituximab, and bortezomib, alone or in combination.1
REVLIMID may help continue the fight against relapsed or refractory MCL1c
26 ORR
%
d
7 CR
%
(34/133)
(9/133)
Overall response rate (CR + CRu + PR)
(95% CI: 18.4, 33.9)
Complete response rate (CR + CRu)
(95% CI: 3.1, 12.5)
• Median time to response was 2.2
16.6
months
(n=34)
median
DOR
Median duration of response
(95% CI: 7.7, 26.7)
months (range: 1.8 to 13 months)
CI=confidence interval; CR=complete response; CRu=complete response unconfirmed; DOR=duration of response; ORR=overall response rate; PR=partial response.
c
Based on all evaluable patients who received ≥1 dose of REVLIMID.1
Print-only committee,
Response was determined based on review of radiographic scans by an independent reviewcontent according to a modified version of the International Workshop Lymphoma
Response Criteria (Cheson, 1999); ORR was defined as: CR + CRu + PR.1,2
d
CONTRAINDICATIONS
Pregnancy:
• REVLIMID can cause fetal harm when administered to a pregnant female. Lenalidomide is contraindicated in females who are pregnant. If this drug is used
during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus
Allergic Reactions:
• REVLIMID is contraindicated in patients who have demonstrated hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis)
to lenalidomide
ADVERSE REACTIONS
Mantle Cell Lymphoma
• Grade 3 and 4 adverse events reported in ≥5% of patients treated with REVLIMID in the MCL trial (N=134) included neutropenia (43%),
thrombocytopenia (28%), anemia (11%), pneumonia (9%), leukopenia (7%), fatigue (7%), diarrhea (6%), dyspnea (6%), and febrile neutropenia (6%)
• Serious adverse events reported in ≥2 patients treated with REVLIMID m