EMA recommends approval of Roche's mAb breast cancer product

By The Science Advisory Board staff writers

November 13, 2020 -- The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Roche's Phesgo, a fixed-dose combination of the monoclonal antibodies (mAbs) pertuzumab (Perjeta) and trastuzumab (Herceptin) with hyaluronidase.

The dose is to be administered by subcutaneous injection along with IV chemotherapy for the treatment of early and metastatic HER2-positive breast cancer. The administration takes approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. The standard IV formulations take approximately 150 minutes for infusion of a loading dose of Perjeta and Herceptin and between 60-150 minutes for subsequent maintenance infusions of the two medicines.

The CHMP's recommendation stems from the phase III FeDeriCa study, which showed treatment with Phesgo produced noninferior levels of Perjeta and Herceptin in the blood when compared with IV administration.

Based on the recommendation, a final decision regarding Phesgo's approval is expected from the European Commission in the near future, Roche said.

Dyno Therapeutics licenses AAV platform to Roche
Dyno Therapeutics has licensed its CapsidMap platform for the development of next-generation adeno-associated virus (AAV) vectors for gene therapies for...
Regeneron, Roche increase supply of COVID-19 antibody cocktail
Regeneron Pharmaceuticals and Roche are joining forces to develop, manufacture, and distribute Regn-COV2, Regeneron's investigational antiviral antibody...
UCB, Roche to develop antibodies for Alzheimer's disease
Biopharmaceutical firm UCB has signed a deal to provide Roche and Genentech with an exclusive, worldwide license to its UCB0107 antitau antibody treatment...
Reverie Labs, Roche to advance kinase drug discovery
Reverie Labs is partnering with Roche and Genentech to advance next-generation kinase inhibitors with the use of artificial intelligence.
Innovent, Roche partner on cell therapies, bispecific antibodies
Innovent Biologics has entered into a research and development collaboration with Roche for multiple cell therapies and bispecific antibodies.

Copyright © 2020 scienceboard.net

Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter