The National Medical Products Administration (NMPA) has granted separate approvals for two distinct drugs from Swiss pharmaceutical giant Roche (SWX: ROG). The first approval is for Phesgo (trastuzumab, pertuzumab), indicated for the treatment of HER2-positive early and metastatic breast cancer. The second approval is for faricimab, which targets neovascular age-related macular degeneration (nAMD).
Phesgo, a ready-to-use fixed dose combination of trastuzumab and pertuzumab, is administered subcutaneously through the thigh. Its approval is supported by the FeDeriCa study, which demonstrated no significant difference in serum drug concentration, pathological complete response rate, and incidence of adverse reactions when compared to trastuzumab dual target intravenous therapy.
Faricimab, on the other hand, is an ophthalmic bispecific antibody (BsAb) that targets antiangiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A). As the world’s first innovative dual pathway retinal treatment drug, it has previously received marketing approval in China for the treatment of diabetic macular edema (DME).- Flcube.com
