FDA advisers back Darzalex, raise concerns over Columvi trial

A panel of experts convened by the US Food and Drug Administration has given a cautious nod to Johnson & Johnson’s (NYSE: JNJ) Darzalex Faspro (daratumumab/hyaluronidase-fihj) for some multiple myeloma patients.

At the same time, the agency’s scientists have raised significant doubts about the suitability of data supporting Roche’s (ROG: SIX) Columvi (glofitamab-gxbm) for earlier use in diffuse large B-cell lymphoma.

The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 6 to 2 that Darzalex has a favorable benefit-risk profile for patients with high-risk smouldering multiple myeloma (HR-SMM), a clinically silent but potentially progressive stage of disease.