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Irina Gontschar: What the Epkinly FDA Review Teaches Us About Sponsor Oversight
Aug 14, 2026, 18:30

Irina Gontschar: What the Epkinly FDA Review Teaches Us About Sponsor Oversight

Irina Gontschar, CEO and Founder at Potter Research Solutions, shared a post on LinkedIn:

”Clinical Development Strategy

Epkinly : Epcoritamab

FDA: The Sponsor Brought Noncompliant Sites Into Compliance

Regulatory Decisions Under Uncertainty

Epkinly is a bispecific antibody developed for the treatment of lymphoma.

During the review of BLA 761324, FDA inspected two clinical research sites, US02 and FR07, and Genmab, the sponsor of Study GCT3013-01.

Study GCT3013-01, ‘An Open-label, Multi-center, Phase 1/2 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of Epcoritamab (GEN3013; DuoBody-CD3xCD20) in Subjects with Relapsed, Progressive or Refractory B-cell Lymphoma’ (NCT03625037).

The sponsor inspection covered Genmab’s conduct of the study and concentrated on review of the aggressive non-Hodgkin lymphoma expansion arm for efficacy and safety.

According to the FDA Clinical Inspection Summary, the inspection included review of

  • study documents,
  • standard operating procedures (SOPs),
  • data collection and handling,
  • investigational product disposition,
  • safety reporting and handling,
  • selection of clinical investigators,
  • sites and monitors,
  • Form FDA 1572s,
  • financial disclosures,
  • Data Monitoring Committee activities,
  • and monitoring files from six clinical sites.

Among those monitoring files, FDA reviewed how Genmab managed two noncompliant sites.

Site FR04 in France was placed on recruitment hold following findings from a sponsor monitoring visit.

Site UK03 in the United Kingdom was placed on recruitment hold following findings from an internal audit.

FDA concluded: ‘Appropriate steps were taken by the sponsor to bring noncompliant sites into compliance.’

FDA also concluded: ‘No sites were found to have inadequate monitoring.’
‘There was no under-reporting of serious adverse events (SAEs).’

No Form FDA 483 was issued to Genmab.

Placing the two noncompliant sites on recruitment hold was an extreme but effective measure.

It brought the sites back into compliance and allowed Genmab to retain control over the study and the integrity of its data.

FDA found the sponsor’s oversight and #monitoring adequate, and Epkinly was approved on May 19, 2023.”

Irina Gontschar: What the Epkinly FDA Review Teaches Us About Sponsor Oversight

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