FDA BRIEF: Week of October 17, 2016

FDA approved


 LARTRUVO (Olaratumab) injection

Eli Lilly and Company, Indianapolis, Indiana, USA

Image result for LARTRUVO

 

INDICATION:  In combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.

UNMET NEED:

  • 12,310 new cases of STS and nearly 5,000 deaths  in 2016
  • New treatment option, added to doxorubicin,  for the initial treatment of soft tissue sarcoma since doxorubicin’s approval more than 40 years ago

REG PATHWAY:  Fast Track, Breakthrough Therapy Designation, Priority Review, Accelerated Approval, Orphan Drug Designation

  • Post Approval Commitment: Randomized, controlled trial to verify and further describe the clinical benefit is STS

MECHANISM OF ACTION: Human IgG1 antibody that binds platelet-derived growth factor receptor alpha (PDGFR-α), expressed on cells of mesenchymal origin and detected on tumor cells.

EFFICACY:

  • Open-label, randomized, active-controlled study (n=133), patients with  soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy,  LARTRUVO in combination with doxorubicin vs.  doxorubicin
  • Endpoints: Overall Survival (OS), Progression-Free Survival (PFS), Objective Response Rate (ORR) assessed by investigator and independent review using RECIST v1.1.
  • Statistically significant improvement in OS: 26.5 mo. vs. 14.7 mo. (p<0.05)
  • PFS: 8.2 mo. vs. 4.4 mo.
  • ORR: 18.2 % vs.  7.5 %

lartruvo.JPG

SAFETY:

  • Serious risks: Infusion-related reactions and embryo-fetal harm
  • Most common side effects: Nausea, fatigue, low levels of white blood cells (neutropenia), musculoskeletal pain, inflammation of the mucous membranes (mucositis), hair loss (alopecia), vomiting, diarrhea, decreased appetite, abdominal pain, nerve damage (neuropathy) and headache.

LABEL


BARRICOR Lithium Heparin Plasma Blood Collection Tubes  (BD Barricor™ Tubes) 

Becton, Dickinson and Company, USA

Image result for Barricor

INDICATION FOR USE: Collect, separate, process, transport and store venous blood samples for use in chemistry determinations, therapeutic drug monitoring (TDM), and zinc testing in plasma for in vitro diagnostic use. It is used in settings where a venous blood sample is collected by a trained healthcare worker.

UNMET NEED:

  • Reduce the amount of blood drawn from each patient for testing
  • Reduce processing time in clinical labs.

REG. PATHWAY: 510(k) – Substantial Equivalence, CFR 862.1675 (Blood specimen collection devices), Class II, Product code: JKA

  • Predicate device: 3 BD Vacutainer® Brand PST™ Plasma Separation Tube

DEVICE DESCRIPTION:

  • Sterile (interior), single-use, evacuated blood collection tubes with  mechanical separator (in place of gel), a low-zinc stopper and a plastic BD Hemogard™ color-coded lime green safety-engineered shield
  • Interior spray coated with lithium heparin anticoagulan
  • Novel separation technology which remains stable in its initial position, to enable the blood to be filled via current methods and subsequently creates a stable, robust barrier during processing

PERFORMANCE CHARACTERISTICS:

Analytical

  •  Precision/Reproducibility, Traceability, Stability, Expected values

Comparison to Comparator:

  • 7 studies in healthy subjects and hospitalized patients
  • Blood samples collected into the BD BarricorTM tubes (candidate device) and the comparator tubes (BD PSTTM (k945952) for chemistry and BD Serum tube (k960250) for TDM)
  • Evaluations  on  selective common general chemistry analytes, immunology analytes, special chemistry analytes, cardiac markers, and therapeutic drug monitoring analytes on multiple instrument platforms
  •  62 analytes (55 chemistry and 7 TDM) evaluated
  • Comparable results between  candidate tube and the comparator tubes.

FDA Decision Summary


 TECENTRIQ (Atezolizumab) injection

Genentech, San Francisco, CA, USA.Image result for tecentriq

INDICATION:  Treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving TECENTRIQ

REG PATHWAY: BLA, Added new indication

MECHANISM OF ACTION: Programmed death-ligand 1 (PD-L1) blocking antibody that previously received FDA accelerated approval for the treatment of locally advanced or metastatic urothelial carcinoma that has progressed after platinum-containing chemotherapy.

EFFICACY:

  • 2  randomized, open-label clinical trials (n=1137) , patients with NSCLC, Compared  atezolizumab vs docetaxel
  • Primary endpoint: Overall Survival (OS)
  • Median OS: 13.8 mo. vs.  9.6 mo, ( p=0.0004, Study 1),  12.6 mo. vs.  9.7 mo (Study 2)

SAFETY:

  • Most common adverse reactions: Fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation
  • Clinically significant immune-related adverse events: Pneumonitis, hepatitis, colitis, and thyroid disease.
Sensor Monitored Alimentary Restriction Therapy (SMART) Device
Scientific Intake, Atlanta, GA, USA
Image result for smart device scientific intake
INDICATION FOR USE: Intended to aid in weight management in overweight to obese individuals. The device is indicated for individuals with a body mass index (BMI) in the range of 27-35 kg/m2 in conjunction with behavioral modification instruction.
REG. PATHWAY: De Novo Request, 21 CFR§ 876.5981
  • Regulation Name: Oral removable palatal space occupying device for weight management and/or weight loss Regulatory
  • Classification: II
  • Product Code: ONY

DEVICE DESCRIPTION:

  • Oral removable palatal space occupying device
  • Worn during meals to limit bite size, thereby reducing the amount of food that is consumed
  • Recording sensors for monitoring patient use

FDA CLASSIFICATION ORDER


 

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