FDA’s Alerts : EFFICACY-SAFETY-QUALITY


Capture.JPGEFFICACY ISSUE identified in clinical trials for some patients taking KEYTRUDA (pembrolizumab, Merck) or TECENTRIQ (atezolizumab, Genentech)

As monotherapy to treat urothelial cancer with low expression of PD-L1

Decreased survival associated with the use of Keytruda  or Tecentriq 

  • Results from 2 two ongoing clinical trials KEYNOTE-361 and IMVIGOR-130
  • Decreased survival vs. patients receiving cisplatin- or carboplatin-based chemotherapy
  • Trial enrollment stopped

Populations differ from those labeled for accelerated approvals of both drugs

  • FDA recommends patient selection per Section 14 of each label

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Capture.JPGPOTENTIAL RISK  of neural tube birth defects with HIV medicine dolutegravir (JULUCA, TIVICAY, TRIUMEQ)

Serious cases of neural tube birth defects involving the brain, spine, and spinal cord d in babies born to women treated with dolutegravir

  • Used to treat human immunodeficiency virus (HIV)
  • Results from an ongoing observational study in Botswana
  • Seen in women taking  dolutegravir in first trimester
  • Neural tube defects occur because spinal cord, brain, related structures do not form properly
  • No reports in women taking drug later in pregnancy
  • Ongoing monitoring will continue

Dolutegravir marketed for 5 years as single ingredient product and fixed dose combination

  • Works by blocking integrase prevent virus from multiplying and reduce amount in body
  • Stopping dolutegravir can cause the HIV infection to become worse

Advice to patients and Health care professionals

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Capture.JPGQUALITY PROBLEMS for data provided by IQVIA used to inform estimates for some controlled substances

Inaccuracy in data provided to FDA by IQVIA National Sales Perspectives database, including data on certain opioid drug products

  • FDA found discrepancy in data that showed a >20% drop in 5-yr fentanyl sales (expressed in kilograms,)  vs. previously reported
  • Past data overestimated because of error in IQVIA’s methods due to wrong weight-based conversion factors
  • Error could impact other federal agencies (eg DEA) using this data; can impact ongoing work to fight opioid epidemic
  • Additional data quality issues related to several other controlled substances  including oxymorphone and hydrocodone
  • Errors raise serious concerns about systemic issues with IQVIA’s data and quality control procedures

Data integrity and validity are critical to FDA and such deficiencies taken very seriously

  • FDA Commissioner has called upon IQVIA to immediately retain qualified independent, third party auditor
  • Conduct complete review of data quality and quality control procedures
  • Hire third party to conduct independent audit of data quality and quality control of all IQVIA products

FDA will brief members of Congress on IQVIA’s data quality issues and their potential public health implications

READ


Image credit: Merck, Genentech, ViiV, IQVIA

 

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