Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, announced that it had entered into a commercial supply agreement with Blueprint Medicines following FDA approval of GAVRETO™ (pralsetinib). Developed by Blueprint Medicines, GAVRETO is a new therapy indicated for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
GAVRETO is a once-daily oral RET-targeted therapy that is designed to selectively and potently inhibit RET alterations that drive many cancer types, including approximately one to two percent of patients with metastatic NSCLC. Currently, RET is one of seven NSCLC biomarkers that can be targeted with an FDA-approved therapy.
“We have a long-standing relationship with Blueprint Medicines, and this approval marks an amazing accomplishment, reflecting the hard work, dedication and determination of the entire team,” commented Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. “The expertise that our scientists in Nottingham brought to the development program supported Blueprint Medicines’ efforts to rapidly gain regulatory approval, and through expedient tech transfer within our company’s global network, our team in Kansas City can effectively support commercial supply.”
In February 2020, Catalent announced a commercial supply agreement for Blueprint Medicines’ AYVAKIT™ (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
Catalent’s Kansas City, Missouri site is home to the company’s Oral & Specialty Drug Delivery business, where it provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The 421,665-square-foot facility is the commercial manufacturing Center-of-Excellence for accelerated development programs and roller compaction. It also houses large-molecule analytical services and provides clinical supply services.
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 14,000 people including around 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey.