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.
Market News and Data brought to you by Benzinga APIs
Posted In: BiotechNewsHealth CareSmall CapFDAGeneralBriefsDLBCLlymphomaPhase 2 Trial
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!