Catalent has agreed to manufacture BRUKINSA (zanubrutinib), an inhibitor that has recently received accelerated approval from the US FDA
Catalent has entered into a long-term commercial supply agreement with BeiGene, a biopharmaceutical company focused on developing and commercialising innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer.
Under the agreement, Catalent will manufacture BRUKINSA (zanubrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor that has recently received accelerated approval from the US FDA as a treatment for mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. BRUKINSA is now commercially available in the US.
Catalent’s Kansas City, Missouri site has supported BeiGene’s programme since 2016, from formulation development and clinical trial supply, onto commercial supply for the US and, subject to further approvals, other markets.
“Our Kansas City facility has an extensive track record in supporting the development and launch of multiple fast-track designation medicines, especially cancer therapies.” said Jonathan Arnold, President of Catalent’s Oral and Specialty Delivery business. “We are pleased to have worked with BeiGene toward this important first approval and we look forward to commercial launch in the US, and to supporting BeiGene as they seek further approvals.”
Commenting on the FDA’s accelerated approval, John V. Oyler, Chairman, Co-Founder, and CEO of BeiGene, said: “The FDA approval of BRUKINSA, following the previously granted Breakthrough Therapy designation in this indication, validates it as an important treatment option for people with relapsed or refractory MCL. We hope this is the first of many approvals for BRUKINSA as we continue to evaluate its potential in other hematologic cancers.”