Roche receives FDA approval for HER2-positive breast cancer combo

Pharmaceutical

The FDA has approved Roche’s Phesgo™, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous injection in combination with IV chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. Approval came on the back of results from the pivotal phase III FeDeriCa study where the combination showed non-inferior levels of Perjeta in the blood during a given dosing interval versus IV administration thereof. The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus Herceptin and chemotherapy, and no new safety signals or meaningful difference in cardiac toxicity were identified.

Phesgo™ is in a single-dose vial and requires about eight minutes to administer for the initial loading dose and around five minutes for each subsequent maintenance dose, as opposed to the two and a half hours required for a sequential infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and the hour to two and a half hours required for subsequent maintenance infusions.

“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“

Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development, said: “The FDA approval of Phesgo reflects our commitment to improving outcomes for the many people living with HER2-positive breast cancer. 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.”

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