In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|November 25, 2019
Catalent to Supply BeiGene’s Brukinsa
Author(s)BioPharm International Editors
The companies announced a commercial supply agreement following FDA’s accelerated approval.
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Catalent announced on Nov. 21, 2019 a commercial supply agreement with BeiGene, Ltd., for the manufacture of Brukinsa (zanubrutinib), a Bruton’s tyrosine kinase inhibitor that received accelerated approval by FDA on Nov. 14, 2019. The drug was approved as a treatment for mantle cell lymphoma in adult patients who have received at least one prior therapy.
In a press statement, Catalent reported that its Kansas City, MO site supported BeiGene’s program in formulation development, clinical trial supply, onto commercial supply for the United States.
“Our Kansas City facility has an extensive track record in supporting the development and launch of multiple fast-track designation medicines, especially cancer therapies,” commented Jonathan Arnold, president of Catalent’s Oral and Specialty Delivery business in the press statement. “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.”
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