FDA Inspection Summary for Ninlaro (ixazomib citrate) by Millennium Pharmaceuticals

FDA did not issue any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the drug approval archives, here is the Clinical Inspection summary for Ninlaro (ixazomib citrate) submitted by Millennium Pharmaceuticals. One clinical study was inspected, with three sites chosen for inspection based on high enrollment and patients with good response to study drug. The site inspections for two sites were completed, with a note that data from the third site was excluded. Site inspections ranged from 4-10 days, and the sponsor inspection lasted 4 days. Two sites received 483s.

Dr. Siegel received a 483 for:

  • Failing to maintain accurate case histories
    • Seven adverse events in three subjects were not captured on the CRF
  • Failing to follow the investigational plan
    • There was no documentation of which reference thermometers were used to calibrate subject refrigerators used to store investigational product.

Dr. Masszi received a 483 for:

  • Failing to follow the investigational plan
    • The date of progressive disease notification did not match the CRF entries for three subjects
    • Discrepancies in number of cartons of specific lots of investigational product received were observed