- European Commission approved ALUNBRIG® (brigatinib), once-daily tablet for adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
- The Lonza team in Tampa, FL (USA) collaborated with Takeda to provide support from early drug product development studies through commercial supply to help bring this new cancer treatment to patients.
- ALUNBRIG is already approved by the U.S. Food and Drug Administration (FDA) for use in this setting in the United States
Basel, Switzerland, 11 January 2019 – Lonza today announced another major milestone in its multiproduct partnership with Takeda. Takeda Pharmaceutical Company Limited announced in November 2018 that the European Commission (EC) granted marketing authorization for ALUNBRIG (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NLSC) previously treated with crizotinib.
Scientists at Lonza Pharma & Biotech's integrated product development and manufacturing facility in Tampa, FL (USA) have collaborated with Takeda on this cancer treatment from product development through commercial approval. The Lonza team has provided support from the original IND and IMPD approvals to formulation, as well as for method and process development for multiple strengths of ALUNBRIG. Lonza's Tampa team also produced clinical material for Phase 1, 2 and 3 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.”