Lonza has reached a major milestone in its multiproduct partnership with Takeda Pharmaceutical Co. Takeda was granted marketing authorization by the European Commission for ALUNBRIG (brigatinib) as a monotherapy for the treatment of anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NLSC) previously treated with crizotinibthe.
 
Lonza Pharma & Biotech’s product development and manufacturing facility in Tampa, FL collaborated with Takeda on this cancer treatment from product development through commercial approval. Lonza provided support from the original IND and IMPD approvals to formulation, as well method and process development for multiple strengths of ALUNBRIG. Lonza also produced clinical material for Phase I, II and III studies and now holds EU GMP certificates for manufacturing, packaging and QC testing of commercial ALUNBRIG.
 
“As Takeda’s partner for the development and manufacture of ALUNBRIG, we are playing a role in helping to bring this oncology drug to the patients who need it,” said Christian Dowdeswell, Lonza’s Dosage Forms & Delivery Solutions Business Unit Head “This approval is an important milestone; and we expect to continue the exceptionally collaborative and highly productive relationship that our two companies have enjoyed over the last six years.”