ADC Therapeutics nabs its first approval as FDA offers a quick OK for its DLBCL cancer treatment
The FDA won’t be waiting around for the PDUFA date for its latest OK on the cancer front.
Regulators came through with an accelerated approval for ADC Therapeutics’ loncastuximab tesirine-lpyl as a third-line therapy for diffuse large B-cell lymphoma, which was basically a shoe-in looking for an OK in drug resistant patients with a priority review attached to the application.
This CD-19 antibody drug conjugate will now be sold as Zynlonta.
The approval comes just under a year after ADC went public, raising a $233 million haul on its second try after posting a 48% overall response rate and a complete response rate of 24% for DLBCL. That’s what they took to regulators.
Following a PRV in November with a review date of May 21, Zylonta’s accelerated nod comes in about a month ahead of schedule. ADC will have to prove the drug’s clinical benefit in a confirmatory study down the road to maintain its marketing approval.
Paolo Caimi at Case Western Reserve University said: “Single-agent Zynlonta demonstrated clinically important outcomes in the pivotal LOTIS-2 study across several disease subtypes. Notably, this included transplant eligible and ineligible patients and patients who previously received stem cell transplant or CAR-T cell therapy.”
Patients had a median time to response of 1.3 months and the median duration of response for the 70 responders was 10.3 months.
There’s no immediate word on price here.
The approval marks a big win for ADC CEO Chris Martin, who helped launch the European company a decade ago and took the helm in 2015, two years after selling Spirogen to AstraZeneca. The biotech raised more than $200 million in a public offering last fall as it prepped for an approval.