FDA BRIEF: Week of Oct 24, 2016

FDA approved


KEYTRUDA (pembrolizumab) injection

Merck and Co., Whitehouse Station, NJ

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INDICATION: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥50%)] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations

UNMET NEED: First FDA approval of a checkpoint inhibitor for first-line treatment of lung cancer

REG. PATHWAY:

  • Breakthrough Therapy designation, Priority Review status, and previously granted Accelerated Approval
  • Current approval converts prior accelerated approval in second-line treatment of metastatic NSCLC patients to regular approval
  • Approved nearly two months before the PDUFA goal date

EFFICACY:

  • Two randomized, multicenter, open-label, active-controlled trial, patients with metastatic NSCLC, whose tumors had high PD-L1 expression [tumor proportion score (TPS) of 50% or greater] by an immunohistochemistry assay using the PD-L1 IHC 22C3 pharmDx Kit , KEYTRUDA vs. chemotherapy, n=305, 1033
  • Statitically significant improvement in  in progression-free survival (PFS) and overall survival (OS)

SAFETY:

  • Most common side effects: Decreased appetite, fatigue, nausea, dyspnea, cough,  constipation
  • Rare but serious adverse events: Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis

Label


 

AMPLATZER PFO Occluder – P120021

St. Jude Medical, Inc., Plymouth, MN, USA

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INDICATION FOR USE:  percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

UNMET NEED:

  • 25 to 30% Americans have a PFO
  • In some patients, PFO provides a path for a blood clot to travel to the brain, blocking a blood vessel resulting in a stroke
  • Patients with a cryptogenic stroke and  PFO may be at increased risk of second stroke
  • No FDA-approved heart occluder devices specifically indicated to close PFOs to reduce the risk of a recurrent stroke in patients with a prior cryptogenic stroke

REG. PATHWAY:

  • Device previously approved under humanitarian device exemption (HDE), but was voluntarily withdrawn in 2006 after FDA concluded target population > 4,000
  • New PMA, Device Code MLV

DEVICE DESCRIPTION:

  • Inserted through a catheter that is placed in a leg vein and advanced to the heart
  • Implanted close to the hole in the heart between the top right chamber (right atrium) and the top left chamber (left atrium)

EFFECTIVENESS AND SAFETY:

  • Single, prospective, randomized, multi-center, event driven trial, n=980,  device closure of a PFO (plus medical management) vs medical management alone
  • Primary effectiveness endpoint: Composite of recurrent nonfatal stroke, fatal ischemic stroke, or post-randomization mortality within 30 days post-implant or 45 days post-randomization
  • Secondary effectiveness endpoints: Absence of transient ischemic attack (TIA) and the rate of complete PFO closureat 6 months follow-up
  •  50% reduction in the rate of new strokes in participants using the Amplatzer PFO

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  • Adverse effects: Injury to the heart, irregular and/or rapid heart rate (atrial fibrillation), blood clots in the heart, leg or lung, bleeding and stroke.

Physician Label

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