The FDA granted initial approval to Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) on June 29, 2020. This approval, sponsored by GENENTECH INC., classifies Phesgo as a Type 4 - New Combination drug.
Background
Phesgo is a new combination drug, consisting of pertuzumab, trastuzumab, and hyaluronidase-zzxf. The FDA's initial approval of this product, sponsored by GENENTECH INC., was designated as a Type 4 - New Combination. This classification indicates that Phesgo represents a novel combination of therapeutic agents.
What this means
The initial FDA approval of Phesgo on June 29, 2020, introduces a new combination drug to the market. This product, comprising pertuzumab, trastuzumab, and hyaluronidase-zzxf, provides clinicians with a new therapeutic option. The classification as a Type 4 - New Combination indicates that Phesgo represents a novel combination of therapeutic agents. This approval makes the combined therapy available for clinical use under the sponsorship of GENENTECH INC.
Source
The information regarding this initial FDA approval was obtained from the U.S. Food and Drug Administration (FDA) website. The approval for BLA761170, concerning Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf), was documented on June 29, 2020. The sponsor for this approval was GENENTECH INC. The official record is accessible via accessdata.fda.gov.