FDA Approvals and Device Classification Orders: OPDIVO, PARSABIV,SEEKER – Drug and Device Digest

FDA BRIEF: Week of January 30, 2017

FDA approved

OPDIVO (nivolumab ) injection

Bristol-Myers Squibb, Princeton, NJ, USA


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INDICATION: Treatment of patients with locally advanced or metastatic urothelial carcinoma who:

  • have disease progression during or following platinum-containing chemotherapy
  • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

REG PATHWAY: Supplemental BLA

  • Accelerated Approval: Based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

MECHANISM OF ACTION: Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells


  • Single study (n=270), locally advanced or metastatic urothelial carcinoma with disease progression, OPDIVO every 2 weeks until unacceptable toxicity/progression
  • Objective response rate (ORR): Assessed by independent committee using RECIST criteria
  • Duration of response (DOR)
  • Complete Resposne=7, Partial Response= 46
  • DOR= 10.3 months


  • Most common adverse reactions: Fatigue, musculoskeletal pain, nausea, and decreased appetite
  • Fourteen patients died from causes other than disease progression, including pneumonitis or cardiovascular failure attributed to nivolumab

Amgen, Thousand Oaks, CA, USA

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INDICATION:  Treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

  • Has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with chronic kidney disease who are not on hemodialysis and is not recommended for use in these populations


MECHANISM OF ACTION: Calcimimetic agent that allosterically modulates calcium-sensing receptor (CaSR) and decreases PTH secretion


  • Two 26-week, randomized, double-blind, placebo-controlled studies
  • Primary outcome measure: Proportion of patients with > 30% reduction in PTH levels from baseline –  weeks 20 through 27
  • Significantly higher proportion of patients treated with PARSABIV achieved a greater than 30% reduction in PTH levels from baseline
  • Reduction in mean PTH, corrected serum calcium, and serum phosphate levels from baseline to the end of study were observed in  PARSABIV arm; statistically significant different from placebo


  • Most common adverse reactions: Blood calcium decreased, muscle spasms, diarrhea, nausea, vomiting, headache, hypocalcemia, and paresthesia
  • Warnings and Precautions: Hypocalcemia,  Worsening Heart Failure,  Upper Gastrointestinal (GI) Bleeding, Adynamic Bone


classSEEKER System

Baebies Inc, Durham, NC, USA



INDICATION FOR USE: Quantitative measurement of the activity of α-L-iduronidase, α-D-glucosidase, β- glucocerebrosidase and α-D-galactosidase A from newborn dried blood spot specimens as an aid in screening newborns for Mucopolysaccharidosis Type I, Pompe, Gaucher and Fabry diseases. Reduced activity of these enzymes may be indicative of these lysosomal storage diseases. The enzymes measured using the SEEKER LSD Reagent KitIDUA|GAA|GBA|GLA and their associated lysosomal storage diseases are listed below.

  • α-L-iduronidase (IDUA)  – Mucopolysaccharidosis Type I (MPS I)
  • α-D-glucosidase (GAA)- Pompe
  • β-glucocerebrosidase (GBA)- Gaucher
  • α-D-galactosidase A (GLA)- Fabry

REG PATHWAY: De Novo Request

  • Regulation Number: 21 CFR 862.1488
  • Regulation Name: Lysosomal storage disorder newborn screening test system
  • Regulatory Classification: Class II
  • Product Code: PQW, PQT, PQU, PQV


  • Inaccurate test results that provide false negative test results could lead to a newborn to not be detected as a possible lysosomal storage disorder case and to be delayed from timely therapy – Special Controls
  • Inaccurate test results that provide false positive test results could lead a newborn to have unnecessary additional confirmatory testing and to add emotional burden to the family of the newborn – Special Controls
  • Special Controls:  Premarket notification submissions with  device performance characteristics of the device, Labeling



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