LAUSANNE, Switzerland– ADC Therapeutics SA (NYSE: ADCT) and Swedish Orphan Biovitrum AB (Sobi®) today announced the European Commission (EC) has granted conditional marketing authorization for the use of ZYNLONTA® (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The approval follows a positive opinion issued in September by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Sobi expects to commence launching ZYNLONTA upon completion of the marketing authorization transfer.
“This approval marks a major milestone in our pursuit to expand the global reach of ZYNLONTA,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. “We are thrilled that ZYNLONTA will be available to help fill a critical unmet need for patients with DLBCL across Europe.”
The approval is based on data from LOTIS-2, a large (n=145) Phase 2 multinational, single-arm clinical trial of ZYNLONTA for the treatment of adult patients with relapsed or refractory DLBCL following two or more prior lines of systemic therapy. In April 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval of ZYNLONTA as the first CD19-targeted antibody drug conjugate (ADC) as a single-agent treatment for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy.
Earlier this year, ADC Therapeutics announced an exclusive license agreement with Sobi to develop and commercialize ZYNLONTA for all hematologic and solid tumor indications in Europe and select international territories. Under the terms of the agreement, the EC approval of ZYNLONTA triggers a $50 million milestone payment from Sobi to ADC Therapeutics.
“We are delighted by the European Commission’s approval of Zynlonta,” said Anders Ullman, Head of Research & Development and Medical Affairs, Chief Medical Officer at Sobi. “We look forward to making Zynlonta available as a new treatment option to patients in the EU impacted by diffuse large B-cell lymphoma, a debilitating disease in haematology.”
The EC decision is valid in all European Union Member States, Iceland, Norway, and Liechtenstein. The EC granted conditional marketing authorization for ZYNLONTA for this indication and continued approval may be contingent upon verification in a confirmatory trial. As a routine part of the marketing authorization process, the EMA’s Committee for Orphan Medicinal Products reviewed ZYNLONTA’s orphan designation and decided not to uphold it.
ADC Therapeutics also has an exclusive license agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications in Japan. In addition, Overland ADCT BioPharma, a joint venture formed by Overland Pharmaceuticals and ADC Therapeutics, is working to develop and commercialize ZYNLONTA in greater China and Singapore. Overland ADCT BioPharma is now conducting a registrational pivotal Phase 2 clinical trial of ZYNLONTA in relapsed or refractory DLBCL in China.
