FDA Clinical Inspection Summary: Akynzeo (netupitant and palonosetron) submitted by Helsinn Healthcare SA

FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Clinical Inspection summary for Akynzeo (netupitant and palonosetron fixed dose combination) submitted by Helsinn Healthcare HA. Sites were selected by FDA to ensure coverage of all trials submitted in the application, high enrollment, geographic diversity, previous inspection history with FDA and feasibility of getting the inspections done within FDA timelines. Six sites plus the sponsor were inspected. Site inspections ranged from three to ten days. The sponsor inspection took place overly nearly two weeks. Three sites were issued FDA Form 483s.

Dr. Csoszi was cited for Failing to records two types of concomitant medication ( Mannisol and Suprastin) on the CRF for twenty four and five patients, respectively. 

Dr. Zajad was cited for failing to follow the investigational plan, specifically:

  • Failing to report two adverse events (fatigue and anemia)
  • The loss of one patient diary after it had been returned to the site by the patient

Dr. Alayosova was cited for failure to maintain accurate case histories, specifically:

  • Discrepancies in medications amounts recorded in patient diaries versus the Case Report Form (CRF) for three subjects.