Celgene

Clinical Inspection Summary: IDHIFA (enasidenib) Submitted by Celgene

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 IDHIFA (enasidenib) submitted by Celgene. Three sites plus the sponsor were inspected. Site inspections ranged from three to five days and the sponsor inspection took place over 4 days. One site received a FDA Form 483.

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

  • Failing to report a headache and a fall in one subject that resulted in a visit to the emergency room.
  • Failing to report hospitalization for nausea and vomiting within twenty four hours as required by the protocol

Page 236 here has the data request showing information FDA expected within five days regarding sites to be potentially inspected. 

Page 127 here shows the FDA requiring analysis excluding subjects who did not have a positive result based on the companion diagnostic. 

FDA Clinical Inspection Summary: Pomalyst (pomalidomide) submitted by Celgene

FDA did not post any warning letters this week to Sponsors/Monitors/CROs, IRBs or Clinical Investigators. From the archives, here is the Clinical Inspection Summary for Pomalyst (pomalidomide) submitted by Celgene. Three sites plus the sponsor were selected for inspection based on the submission of a single Phase 1/2 study. Site inspections ranged from six to twenty days and the sponsor inspection ranged over one month. One site and the sponsor received an FDA Form 483.

Dr. Siegel was cited for failing to maintain adequate investigational product accountability. Specifically, the records for three subjects did had discrepancies of two to five capsules. 

Celgene was cited for the following:

  • Inadequate monitoring of the study
    • The monitoring plan required investigational product accountability to be performed at every visit.
    • FDA review of monitoring visit reports determined that for three sites investigational product accountability was done at half or less than half the visits.
    • Four monitoring visit reports lacked a description of investigational product accountability activities by the monitor at the visit. 
    • Investigational product accountability records lacked lot numbers and quantities of investigational product destroyed by a third party. 
  • Inadequate labeling of investigational product
    • The investigational drug labeling lacked directions to the patient to take at least two hours before or after eating. 

Clinical Inspection Summary: Otezla (apremilast) by Celgene

FDA did not issue any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the clinical inspection summary for Otezla (apremilast) by Celgene. Three sites were selected due to high enrollment, relatively high percentage of treatment responders and randomization irregularities. Site inspections lasted ranged from four to eight days. One site received an FDA form 483.

Dr. Wasel was cited for failing to reconsent subjects to an updated informed consent form at their next visit. FDA also noted that only one study coordinator had access to an electronic system called Sitepad and Studyworks for recording  investigator assessments, and appears to note that the investigator should have had access to this electronic data as well.