FDA Approves ADC Therapeutics' Zynlonta

Global contract development and manufacturing organization (CDMO), Sterling Pharma Solutions, said that its customer, ADC Therapeutics SA, has received FDA approval for the antibody drug conjugate (ADC) Zynlonta (loncastuximab tesirine-lpyl) that its Deeside facility contributed to developing.

Zynlonta has been granted accelerated approval by the FDA for use in adult patients with relapsed or refractory B-cell lymphoma (DLBCL), including DLBCL not otherwise specified (NOS), DLBCL arising from low grade lymphoma and also high-grade B-cell lymphoma, and is now commercially available in the United States. The drug addresses a significant need for treatment options for patients with DLBCL, the most common type of non-Hodgkin lymphoma in the U.S..

Sterling’s dedicated bioconjugation team, based at its Deeside, Wales facility in the UK, has worked in close collaboration with ADC Therapeutics for almost a decade. The teams have worked on the Zynlonta project since 2014, when loncastuximab tesirine-lpyl (aka ADCT-402) was nominated as the lead candidate. Sterling established a scalable process and supporting analytics, then transferred these into a CMO for clinical manufacturing and performed process characterisation studies in support of the Biological License Application.

“I am delighted by this success for ADC Therapeutics,” said Colin McKee, head of technical services at Sterling. “Our bioconjugation team has been working with the team at ADC Therapeutics for so many years, and it has been a real pleasure to play a part in establishing the pyrrolobenzodiazepine ADC payload platform as another validated weapon in the fight against cancer.

“It is incredibly rewarding to work with a team that’s values align so well with our own, and our work over the years has seen us develop into a truly collaborative team which has allowed us to share in this recent success.”

Patrick van Berkel, senior vice president, research and development, ADC Therapeutics, said, “We thank Sterling for their significant contribution to getting ZYNLONTA approved. We appreciate everything the Deeside team has done for us throughout the years. It is fantastic to be able to rely on such a steady, high quality team that will always deliver.”

Sterling continues to work closely with ADC Therapeutics who have multiple ADCs currently in preclinical and clinical development.