ADC Therapeutics receives FDA approval for its lymphoma cancer treatment ZYNLONTA

Oncology biotechnology company ADC Therapeutics has received the first FDA approval for ZYNLONTA, its lead drug candidate for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.

ADC Therapeutics’ ZYNLONTA demonstrated 48.3% overall response rate, 24.1% complete response rate and durable responses in heavily pretreated patients in pivotal LOTIS-2 trial.

Diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma in the United States, is a rapidly progressing, aggressive disease that is heterogeneous with multiple subtypes. More than 40% of first-line DLBCL treatments fail.

ADC Therapeutics’ late-stage candidate ZYNLONTA is the first and only CD19-targeted antibody-drug conjugate (ADC) which can be used as a single-agent treatment for adult patients.

Based on the overall positive response rates obtained during clinical trials, ZYNLONTA has been granted accelerated approval by the FDA (U.S. Food and Drug Administration).

An important milestone for ADC Therapeutics

With the approval, ZYNLONTA will be commercially available in the United States shortly. The company based at the Biopôle in Epalinges (canton of Vaud) has also launched the Advancing Patient Support Program, a comprehensive patient support program offering financial assistance, ongoing education and other resources to eligible patients who are prescribed ZYNLONTA. 

“The FDA approval of ZYNLONTA is an exciting advancement for patients with r/r DLBCL and a transformational event for ADC Therapeutics,” said Chris Martin, CEO of ADC Therapeutics. “We extend our deepest gratitude to the patients who participated in our LOTIS-1 and LOTIS-2 clinical trials, their families, the study investigators and our employees, as their commitment made this important milestone possible.”

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