FDA Brief: Week of February 20, 2017
FDA approved


  Image result for Vidas Brahms PCT AssayVIDAS BRAHMS TEST

bioMérieux Inc. in Marcy l’Etoile, France

INTENDED USE: Automated test for determination of human procalcitonin (PCT) in human serum or plasma (lithium heparin) using the Enzyme-Linked Fluorescent Assay (ELFA) technique. For use in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock.

INDICATION FOR USE: Help manage antibiotic treatment for lower respiratory tract infections and sepsis. Intended to be used in the hospital or emergency room

UNMET NEED:

  • Unnecessary antibiotic use contribute to antibiotic-resistant infections
  • Need to determine if antibiotic treatment be started/stopped in patients with lower respiratory tract infections
  • This is the first test to use PCT as a biomarker to help make antibiotic management decisions

REG PATHWAY: 510(k) for Expanded Use

  • 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.

Image result for Revlimid

REVLIMID (Lenalidomide)

Celgene Corporation Summit, NJ, USA

INDICATION:   Maintenance therapy in patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT)

REG PATHWAY: SNDA

  • 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

EFFICACY:

  • 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

SAFETY:

  • Similar to previously described in  product label

LABEL


 

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