FDA Lifts Hold on Macrogenics Gynecological Cancer Treatment Trial

By Katherine Hamilton

Macrogenics said the Food and Drug Administration has lifted its partial clinical hold on the oncology company's trial of a cancer treatment.

The hold has been lifted for a Phase 2 study of lorigerlimab as a treatment for gynecological cancers.

The FDA placed a hold on the study in February due to safety issues. Four patients experienced safety events, including thrombocytopenia, myocarditis, neutropenia and concurrent septic shock.

During the hold, existing study participants were able to continue receiving the study drug, the clinical-stage biopharmaceutical company said Wednesday. New participants will be enrolled under a revised protocol that includes additional risk mitigation.

Chief Executive Eric Risser said Macrogenics plans to resume enrollment and is on track to provide a mid-year clinical update.

Write to Katherine Hamilton at [e-mail]

(END) Dow Jones Newswires

04-08-26 1724ET