95%CI) Duration of Response, in months
Median (95% CI) Range
CR 32 (23, 42) 20.5 (12.0, NE* ) 1.4 to 21.9†
PR 40 (32, 49) 3.5 (2.2, 4.1) 1.3 to 18.7
ORR 73 (65, 83) 6.7 (4.0, 14.8) 1.3 to 21.9†
14.2 Systemic Anaplastic Large Cell Lymphoma
The efficacy of ADCETRIS in patients with relapsed sALCL was eva luated in one phase 2 open-label, single-arm, multicenter trial. This trial included patients who had sALCL that was relapsed after prior therapy. Fifty-eight patients were treated with 1.8 mg/kg of ADCETRIS administered intravenously over 30 minutes every 3 weeks. An independent review facility performed efficacy eva luations which included overall response rate (ORR = complete remission [CR] + partial remission [PR]) and duration of response as defined by clinical and radiographic measures including computed tomography (CT) and positron-emission tomography (PET) as defined in the 2007 Revised Response Criteria for Malignant Lymphoma (modified).
The 58 patients ranged in age from 14-76 years (median, 52 years) and most were male (57%) and white (83%). Patients had received a median of 2 prior therapies; 26% of patients had received prior autologous stem cell transplant. Fifty percent (50%) of patients were relapsed and 50% of patients were refractory to their most recent prior therapy. Seventy-two percent (72%) were anaplastic lymphoma kinase (ALK)-negative.
The efficacy results are summarized in Table 3. Duration of response is calculated from date of first response to date of progression or data cutoff date.
Table 3: Efficacy Results in Patients with Systemic Anaplastic Large Cell Lymphoma *
Not estimable
†
Follow up was ongoing at the time of data submission.
N = 58
Percent (95%CI) Duration of Response, in months
Median (95% CI) Range
CR 57 (44, 70) 13.2 (10.8, NE* ) 0.7 to 15.9†
PR 29 (18, 41) 2.1 (1.3, 5.7) 0.1 to 15.8†
ORR 86 (77, 95) 12.6 (5.7, NE* ) 0.1 to 15.9†
Not estimable
†
Follow up was ongoing at the time of data submission.
N = 58
Percent (95%CI) Duration of Response, in months
Median (95% CI) Range
CR 57 (44, 70) 13.2 (10.8, NE* ) 0.7 to 15.9†
PR 29 (18, 41) 2.1 (1.3, 5.7) 0.1 to 15.8†
ORR 86 (77, 95) 12.6 (5.7, NE* ) 0.1 to 15.9†
15 REFERENCES
NIOSH Alert: Preventing occupational exposure to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165
OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. (2006) 63:1172-1193
Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
ADCETRIS (brentuximab vedotin) for Injection is supplied as a sterile, white to off-white preservative-free lyophilized cake or powder in individually-boxed single-use vials:
NDC (51144-050-01), 50 mg brentuximab vedo
