- A committee of the European Medicines Agency (EMA) recommended the approval of ADC Therapeutics ( NYSE: ADCT ) and Swedish Orphan Biovitrum's (Sobi) Zynlonta (loncastuximab tesirine) in EU to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
- The positive opinion by the EMA's Committee for Medicinal Products for Human Use (CHMP) was backed by data from a phase 2 trial called LOTIS-2.
- Approval decision from the European Commission's (EC), which generally follows the opinion of the CHMP, is expected in Q4 2022, the companies said in a Sept. 16 press release.
- ADC has license agreements for Zynlonta with Sobi and Mitsubishi Tanabe Pharma for certain regions.
For further details see:
ADC, Sobi Zynlonta for blood cancer subtype gets EMA panel backing for EU approval