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Lonza and Takeda have furthered their multiproduct partnership through collaborative efforts on a new cancer treatment-Alunbrig (brigatinib).
Lonza and Takeda have furthered their multiproduct partnership through collaborative efforts on the new monotherapy for patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NLSC) previously treated with crizotinib-Alunbrig (brigatinib).
The teams have collaborated to develop the drug product all the way through to commercial approval. Scientists from Lonza Pharma & Biotech’s integrated product development and manufacturing facility in Tampa, FL, worked with Takeda to support the original investigational approvals to formulation, as well as for method and process development for multiple strengths of Alunbrig.
Additionally, the Lonza Tampa team produced clinical material for Phase I, II, and III studies and as such is the holder of EU GMP certificates for manufacturing, packaging, and quality control 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 in a Jan. 11, 2019 press release. “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.”
Alunbrig, received marketing authorization from the European Commission in November 2018 and is already approved by FDA for use in the United States for the aforementioned indication.