y significant improvement in PFS for patients randomized to CAPRELSA (Hazard Ratio (HR) = 0.35; 95% Confidence Interval (CI) = 0.24-0.53; p<0.0001). Analyses in the subgroups of patients who were symptomatic or had progressed within 6 months prior to their enrollment showed similar PFS results (HR = 0.31 95% CI: 0.19, 0.53 for symptomatic patients; HR = 0.41 95% CI: 0.25, 0.66 for patients who had progressed within 6 months prior to enrollment).
At the time of the primary analysis of PFS, 15% of the patients had died and there was no significant difference in overall survival between the two treatment groups. The overall objective response rate (ORR) for patients randomized to CAPRELSA was 44% compared to 1% for patients randomized to placebo. All objective responses were partial responses.
Figure 1- Progression Free Survival
Table 3:
|
Progression-Free Survival (PFS) |
N* |
Median PFS (95% CI) |
HR |
95% CI |
p-value |
|
|
|
CAPRELSA 300 mg
|
59/231 (26%)
|
Not reached (22.6 months, NE§)
|
0.35
|
0.24, 0.53
|
<0.0001
|
|
Placebo
|
41/100
|
16.4 Months (8.3, 19.7)
|
Summary of key efficacy findings
15. REFERENCES
NIOSH Alert: Preventing occupational exposures 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
100 mg Tablets Available in bottles containing 30 tablets (NDC 0310–7820–30).
300 mg Tablets Available in bottles containing 30 tablets (NDC 0310–7840–30).
16.1. Storage and Handling
CAPRELSA tablets should be stored at 25°C (77°F); excursions permitted to 15oC – 30oC (59oF – 86oF) [See USP controlled room temperature].
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-4 CAPRELSA tablets should not be crushed. Direct contact of crushed tablets with the skin or mucous membranes should be avoided. If such contact occurs, wash thoroughly as outlined in the references. Personnel should avoid exposure to crushed tablets.
17. PA |
