ADC Therapeutics' Zynlonta gains US approval for r/r DLBCL

On Friday, Swiss antibody-drug conjugate specialist ADC Therapeutics (NYSE: ADCT) saw its shares gain almost 5% to $24.40 after-hours, as it revealed that the US Food and Drug Administration has granted accelerated approval for Zynlonta (loncastuximab tesirine-lpyl).

The drug is cleared for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low grade lymphoma and high-grade B-cell lymphoma.

Zynlonta is the first and only CD19-targeted antibody drug conjugate (ADC) for the treatment of r/r DLBCL. Zynlonta fills a significant unmet need in r/r DLBCL in heavily pre-treated patients with difficult to treat disease and has the potential to become the standard of care in 3L+ DLBCL. The 3L+ DLBCL total market consists of 10,500 patients in the USA/EU5 and represents a $1 billion+ opportunity, according to the company.