Daiichi Sankyo Europe GmbH

CDMO Market Report: Key Regulatory Approvals and Clinical Advances in March-April 2025

a month ago

• Multiple CDMOs secured significant contract manufacturing opportunities as regulatory bodies approved new indications for established drugs, particularly in oncology and rare diseases. • AstraZeneca's portfolio saw substantial growth with expanded approvals for Imfinzi, Tagrisso, and Lynparza, strengthening partnerships with contract manufacturers including Lonza, Dottikon, and Samsung Biologics. • Contract manufacturers supporting treatments for autoimmune conditions showed strong performance, with Argenx's Vyvgart Hytrulo receiving expanded indications for myasthenia gravis and CIDP.

Enhertu Approved for HER2-Low and HER2-Ultralow Metastatic Breast Cancer

5 months ago

• The FDA has approved Enhertu for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer after endocrine therapy progression. • DESTINY-Breast06 trial data showed a 36% reduction in disease progression or death risk compared to chemotherapy. • Patients on Enhertu had a median progression-free survival of 13.2 months versus 8.1 months on chemotherapy. • This approval expands Enhertu's use to an earlier treatment setting and a broader patient population.

Nivolumab Plus Chemotherapy Shows QOL Benefits and High Response in Urothelial Cancer Subsets

8 months ago

• The CheckMate 901 trial showed nivolumab plus chemotherapy maintained quality of life (QOL) compared to chemotherapy alone in urothelial carcinoma patients. • A subset analysis of CheckMate 901 revealed a high complete response rate (63%) in patients with lymph node-only metastatic urothelial cancer treated with nivolumab plus chemotherapy. • Early data on sacituzumab govitecan plus ipilimumab and nivolumab showed promising response rates but was halted due to unexpected immune myocarditis. • The combination of antibody-drug conjugates and immune checkpoint inhibitors remains a promising strategy but requires careful management of toxicities.