ADC Therapeutics’ (NYSE: ADCT) share price has risen more than 20% in early Wednesday trading after it announced that the European Commission (EC) has granted conditional marketing authorisation for ZYNLONTA.
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The conditional marketing authorisation is for the use of ZYNLONTA to treat relapsed or refractory diffuse large B-cell lymphoma.
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“This approval marks a major milestone in our pursuit to expand the global reach of ZYNLONTA,” stated 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.”
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The approval comes after a positive opinion issued in September by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Earlier this year, ADC Therapeutics announced an exclusive license agreement with Swedish Orphan Biovitrum AB (Sob) to develop and commercialize ZYNLONTA in Europe and select international territories.
Sobi expects to commence launching ZYNLONTA upon completion of the marketing authorization transfer. The approval, which is valid in all European Union Member States, Iceland, Norway, and Liechtenstein, has also triggered a $50 million milestone payment from Sobi to ADC Therapeutics.
Anders Ullman, Head of Research & Development and Medical Affairs, and Chief Medical Officer at Sobi, said the company was “delighted by the European Commission’s approval of Zynlonta.”
“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.”
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