- The European Commission (EC) granted conditional marketing authorization to ADC Therapeutics ( NYSE: ADCT ) and Swedish Orphan Biovitrum's (Sobi) Zynlonta (loncastuximab tesirine) to treat to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in the EU.
- The EC approval was backed by data from a phase 2 trial called LOTIS-2. The decision follows a recommendation for approval by a panel of the the European Medicines Agency (EMA) in September.
- The EC approval triggers a $50M milestone payment from Sobi to ADC, according to the companies.
- ADC said continued approval may be contingent upon verification in a confirmatory trial.
- The company added that the EMA's Committee for Orphan Medicinal Products reviewed Zynlonta's orphan designation and decided not to uphold it.
- ADC has license agreements for Zynlonta with Sobi and Mitsubishi Tanabe Pharma for certain regions.
- ADCT +30.50% to $4.15 premarket Dec. 21
For further details see:
ADC Therapeutics stock soars 30% as Zynlonta gets approval in EU for blood cancer subtype