FDA approves Roche’s Phesgo, a Fixed-Dose Combination Breast Cancer Drug

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Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.

On June 29, 2020, FDA approved Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous (SC) injection. The product was approved for use in combination with intravenous (IV) chemotherapy for treating early and metastatic HER2-positive breast cancer. Patients should be selected based on an FDA-approved companion diagnostic test, according to an FDA press release. The agency granted the approval to Genentech, a Roche company.

Phesgo is initially used in combination with chemotherapy and could continue to be administered at home by a qualified health care professional once the chemotherapy regimen is finished, the agency stated in the press release.

FDA’s approval was based on the results of a non-inferiority study in patients with HER2-positive early breast cancer. The results demonstrated that Phesgo had comparable efficacy and safety to IV pertuzumab and IV trastuzumab, except for administration-related reactions, which were higher with Phesgo because of the subcutaneous route of administration, the agency said in a press release.

“Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. With a new administration route, Phesgo offers an out-patient option for patients to receive trastuzumab and pertuzumab,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in FDA’s Center for Drug Evaluation and Research, in the press release.

“As part of [FDA’s] ongoing commitment to address the novel coronavirus pandemic, we continue to keep a strong focus on patients with cancer who constitute a vulnerable population at risk of contracting the disease. At this critical time, we continue to expedite oncology product development. This application was approved about four months ahead of the FDA goal date,” Pazdur added.


“The FDA approval of Phesgo reflects our commitment to improving outcomes for the many people living with HER2-positive breast cancer,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, Roche, in a Roche company press release. “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.”

Phesgo is available in one single-dose vial. Administration can take approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. This is compared to approximately 150 minutes for a sequential infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations and between 60 and 150 minutes for subsequent maintenance infusions of the two medicines, according to Roche in their press release.

This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection, the company stated in its press release.

Source: FDA and Roche