ADC Therapeutics step closer to loncastuximab tesirine approval

Shares of Swiss antibody-drug conjugate specialist ADC Therapeutics (NYSE: ADCT) gained 5.4% to $35.76 this morning after it revealed that the US Food and Drug Administration has accepted its Biologics License Application (BLA) for loncastuximab tesirine (proposed trade name Lonca) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and granted priority review status.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of May 21, 2021.

“The FDA’s acceptance of our BLA and granting of priority review for Lonca is a tremendous accomplishment that brings ADC Therapeutics one step closer to being able to offer patients with relapsed or refractory DLBCL a greatly needed new treatment option in 2021,” said Chris Martin, chief executive of ADC Therapeutics, adding: “We look forward to working with the FDA during its review of our BLA submission for Lonca. Our organization remains focused on robust planning for a successful launch next year.”