- 21CFR 866.3610, Endotoxin activity
- Classification: Class II
- Product code: NTM – Antigen, inflammatory response marker, sepsis
EFFECTIVENESS & RISKS:
- Meta-analysis of clinical trial findings from published literature that compared PCT-guided therapy to standard therapy
- Prospective, randomized studies showed a significant decrease in antibiotic use for patients who had received PCT-guided therapy, without significantly affecting safety.
- Risks: False positive results leading to unnecessary treatment with antibiotics, False negative results leading to delay in selection of appropriate therapy.
- 2006: Initial approval for use with dexamethasone in patients with multiple myeloma with one prior therapy
- 2015: Expanded indication to include newly diagnosed multiple myeloma patients who are not eligible for autologous stem cell transplant
- 2 randomized controlled studies in patients who had undergone induction therapy followed by auto-HSCT; vs placebo
- Major efficacy endpoint: Progression Free Survival ( PFS) from randomization to progression/death. Not powered for Overall Survival (OS)
- PFS: 15-month and 18-month advantage, p<0.001
- Median OS: 111 and 106 months vs. 84 and 88 months
- Similar to previously described in product label