Multiple new CAR-T medicines against diffuse large B-cell lymphoma (DLBCL) have hit the market in recent years, improving prospects for patients and extending the array of available options for doctors. Now, with an FDA approval Friday afternoon, ADC Therapeutics is getting ready to launch the first single-agent CD19-targeted antibody-drug conjugate therapy against the disease.
ADC Therapeutics scored an FDA nod for Zynlonta, formerly known as loncastuximab, as a solo treatment for adult patients with relapsed or refractory DLBCL after two prior lines of therapy.
The FDA endorsed the drug based on data from a multinational phase 2 trial called Lotis-2 in patients with r/r DLBCL after two lines of therapy. 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.
The med scored an accelerated approval, meaning the company may have to demonstrate the med's efficacy in a confirmatory trial to retain the licensure.
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ADC filed the data with the FDA in September and scored a priority review for the application in November.
Zynlonta joins a series of DLBCL drugs to score approvals in recent years, including CAR-T meds from Novartis, Gilead Sciences and Bristol Myers Squibb. Other meds eyeing the indication include MorphoSys and Incyte’s CD19 antibody Monjuvi and Roche’s anti-CD79b ADC Polivy.