Roche’s Phesgo combo secures US approval for metastatic HER2-positive breast cancer

pharmafile | June 30, 2020 | News story | Manufacturing and Production, Sales and Marketing |  FDA, Phesgo, Roche, US, breast cancer 

The FDA has awarded marketing authorisation in the US to Roche’s Phesgo, a combination of subcutaneously injected Herceptin (trastuzumab) with hyaluronidase, alongside intravenous chemotherapy in the treatment of early and metastatic HER2-positive breast cancer.

The US regulator moved to approve the therapy based on Phase 3 data demonstrating Phesgo generated non-inferior levels of Perjeta in the blood during a dosing interval compared to intravenous Perjeta alone, hitting its trial’s primary endpoint. Meanwhile at Phase 2, the therapy, delivered by IV, was preferred by 85% of 160 participants for the treatment of HER2-positive breast cancer.

“The FDA approval of Phesgo reflects our commitment to improving outcomes for the many people living with HER2-positive breast cancer,” explained Dr Levi Garraway, Chief Medical Officer and Head of Global Product Development. “Phesgo offers a treatment administration that supports the needs and preferences of individual patients, and helps to meet the increasing demand across the healthcare system for faster and more flexible treatment options.”

The combo therapy is the first to combine two of Roche’s monoclonal antibodies into a single subcutaneous injection. It can be administered in eight minutes for an initial dose and in five for a maintenance dose, a fragment of time compared to the 150 minutes required for a sequential intravenous infusion of Perjeta and Herceptin.

Matt Fellows