ADC Therapeutics' Zynlonta confirmatory trial shows higher death rates, clouding full approval prospects

ADC Therapeutics is pursuing full FDA approval for its antibody-drug conjugate Zynlonta in patients with relapsed or refractory diffuse large B-cell lymphoma.

In the confirmatory study presented, the company reported death rates that were higher than expected, raising safety concerns.

These findings could complicate the regulatory review and potentially delay the approval timeline.

The situation highlights the heightened scrutiny of late-stage oncology trials and may prompt additional data requests from regulators.