The National Medical Products Administration (NMPA) of China has granted approval to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for use as a monotherapy in adult patients with unresectable or metastatic HER2-low breast cancer. The approval applies to patients who have undergone prior systemic therapy in a metastatic setting or experienced disease recurrence within six […]
Enhertu FDA approval : AstraZeneca and Daiichi Sankyo have secured approval for Enhertu (trastuzumab deruxtecan) from the US Food and Drug Administration for the treatment of a type of metastatic breast cancer in adult patients. Enhertu is said to be a specifically engineered HER2-directed antibody drug conjugate (ADC). It is being co-developed and commercialized by […]
Lynparza EMA approval : Pharma giants AstraZeneca and MSD have secured an expansion of the European Medical Agency’s (EMA) approval for their poly ADP-ribose polymerase (PARP) inhibitor Lynparza (olaparib) to be used for the treatment of a type of advanced breast cancer. The expanded Lynparza EMA approval allows the PARP inhibitor to be used as […]
AstraZeneca has achieved a major regulatory milestone with the US Food and Drug Administration (FDA) approval of Lumoxiti (moxetumomab pasudotox-tdfk), a CD22-directed cytotoxin for the treatment of relapsed or refractory hairy cell leukemia (HCL). This approval marks a significant advancement in the treatment of this rare and chronic form of leukemia, offering new hope to […]