Lonza, Takeda reach regulatory milestone in oncology tie-up

By Maggie Lynch

- Last updated on GMT

(Image: Getty/Oatawa)
(Image: Getty/Oatawa)

Related tags Oncology Clinical development Packaging Supply chain Supply chain management marketing authorization Marketing

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. 

Related news

Show more

Related products

show more

Ultra Low Temperature Packaging solutions

Ultra Low Temperature Packaging solutions

Content provided by Almac Group | 12-Feb-2024 | Case Study

Advanced Therapy Medicinal Products (ATMPs) offer ground-breaking opportunities for treating injuries and disease, in particular for cases of severe, untreatable...

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Related suppliers

Follow us

Products

View more

Webinars