ADC Therapeutics gains EU clearance for Zynlonta

Sobi and ADC Therapeutics SA announced that the European Commission (EC) has granted conditional marketing authorisation 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 of the European Medicines Agency (EMA).

In July, Sobi announced an exclusive license agreement with ADC Therapeutics to develop and commercialise Zynlonta for use in haematology and other indications of large unmet medical need in Europe and most international markets. The license agreement aimed at augmenting Sobi's presence in haematology, one of Sobi's two main disease areas. Zynlonta will be made commercially available alongside other Sobi haematology medicines.

"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 EC decision is valid in all European Union member states, Iceland, Norway and Liechtenstein. As a routine part of the marketing authorisation process, the EMA's Committee for Orphan Medicinal Products reviewed the orphan designation and decided not to uphold it.

Diffuse large B-cell lymphoma (DLBCL) is an aggressive and malignant disease in haematology with an incidence in Europe of approximately 8.8 cases per 100,000 adults per year. As many as 40 per cent of all patients with DLBCL will need at least a 2nd-line treatment as their disease is relapsing or refractory. For those patients, effective treatment options are limited, representing a critical unmet need.

(Press release / SK)