ADC Therapeutics Stock Jumps On Scoring First FDA Approval For DLBCL Treatment

ADC Therapeutics SA ADCT has scored an FDA approval for Zynlonta, formerly known as loncastuximab tesirine, as a solo treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two prior lines of therapy.
Following a priority review in November with a review date of May 21, Zylonta’s accelerated nod comes a month ahead of schedule.
The company will have to prove its clinical benefit in a confirmatory study to maintain its marketing approval.
The approval comes just under a year after ADC went public, raising $233 million.
The FDA endorsed the drug based on data from a Phase 2 trial, LOTIS 2. The drug turned in an overall response rate of 48.3%, and, for those who responded, the median duration of response was 10.3 months. More than 24% of patients experienced a complete response.
Price Action: ADCT shares are up 5.72% at $24.58 in the premarket session on the last check Monday.