iteria (IWC). The key secondary efficacy endpoint was duration of response. Response assessments were scheduled at the end of cycle 1 and then every other cycle (every 14 weeks). Duration of response was measured from the first day of documented response to disease progression or death. Response and disease progression were eva luated by independent central review using the IWC.
The median age of treated patients was 59.0 years (range21-85); 68% were male and 32% were female. Most patients were White (72%) and other racial origins included: Black (13%), Hispanic (8%), Asian (5%), other and unknown (<1% each). Patients had an Eastern Cooperative Oncology Group (ECOG) performance status at study entry of 0 (39%), 1 (44%), or 2 (17%). The median time from initial diagnosis to study entry was 15.6 months (range 0.8 – 322.3).
The median number of prior systemic therapies was 3 (range 1-12). Approximately one-fourth of patients (24%, n = 27) did not have evidence of response to any previous therapy. Approximately two-thirds of patients (63%, n = 70) did not have evidence of response to their most recent prior therapy before entering the study.
In all eva luable patients (n = 109) treated with FOLOTYN, the response rate, as determined by independent central review by IWC, was 27% (n = 29) (Table 5).
Table 5 Response Analysis per Independent Central Review (IWC) eva luable Patients
(N=109)
Fourteen patients went off treatment in cycle 1; 2 patients were uneva luable for response by IWC due to insufficient materials provided to central review.
CR = Complete Response, CRu = Complete Response unconfirmed, PR = Partial Response
N (%) 95% CI Median Duration of Response Range of Duration of Response
Overall Response
CR+CRu+PR 29 (27) 19, 36 287 days
(9.4 months) 1-503 days
CR/CRu 9 (8)
PR 20 (18)
Responses ≥ 14 weeks
CR+CRu+PR 13 (12) 7, 20 Not Reached 98-503 days
CR/CRu 7 (6)
PR 6 (6)
The initial response assessment was scheduled at the end of cycle 1. Of the responders, 66% responded within cycle 1. The median time to first response was 45 days (range 37-349 days).
15 REFERENCES
Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 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
FOLOTYN is available in single-use clear glass vials containing pralatrexate at a concentration of 20mg/mL as a preservative-free, sterile, clear yellow solution individually packaged for intravenous use in the following presentations:
NDC 48818-001-01: 20 mg of pralatrexate in 1 mL solution in a vial (20 mg / 1 mL)
NDC 48818-001-02: 40 mg of pralatrexate in 2 mL solution in a vial (40 mg / 2 mL)
Vials must be stored refrigerated at 2-8°C (36-46°F) (see USP Controlled Cold Temperature) in original carton to protect
