European Commission has approved brigatinib (Alunbrig?; Takeda), a once-daily tablet for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib (Xalkori?; Pfizer).
To help develop the novel drug, scientists at Lonza Pharma & Biotech?s integrated product development and manufacturing facility 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.
Based on the multiproduct partnership with Takeda Pharmaceutical Company announced in November 2018, Loza collaborated with Takeda scientists in developing this novel 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 brigatinib.
The Lonza team in Tampa also produced clinical material for Phase I and Phase II, studies and now holds EU GMP certificates for manufacturing, packaging and QC testing of commercial brigatinib.
?As Takeda?s partner for the development and manufacture of brigatinib, we are playing a role in helping to bring this oncology drug to the patients who need it,? explained Christian Dowdeswell, Lonza?s Dosage Forms & Delivery Solutions Business Unit Head
?This approval by the European regulators 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,? Dowdeswell concluded
Last Editorial Review: January 11, 2019
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