Lonza, Takeda reach regulatory milestone in oncology tie-up

17-Jan-2019 - Last updated on 17-Jan-2019 at 17:30 GMT

(Image: Getty/Oatawa)

Lonza provided development, manufacturing, and clinical packaging services for Takeda’s Alunbrig, which has received EMA marketing authorization.

Alunbrig (brigatinib), indicated for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC), received marketing authorization by the European Medicines Agency (EMA).

Ben Sahacic, director of commercial development at Lonza told us, “Lonza provided validation and regulatory submission support with Takeda leveraging benefits of a simplified supply chain with development, manufacturing, and clinical packaging in a single location in Tampa, Florida for both US and EU submissions.”

Lonza’s FL-based facility provided services for both US and EU submissions. Additionally, it produced clinical material for Phase I, II and II studies.

“Lonza will provide ongoing manufacturing product-resupply activities for brigatinib, while, in parallel, engaging in assessment of further collaboration on new oncology programs,” Sahacic stated.

According to Sahacic, Takeda is a “strategic client” for the advancement of oncology platforms for both clinical and commercial settings.