FDA okays novel breast, colorectal cancer treatments


Colorectal cancer drug is the first immunotherapy administered as a first-line treatment and without chemotherapy.

In the past week, FDA cleared two novel cancer treatments — one for breast cancer and the other for colorectal cancer.

FDA cleared a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf (Phesgo, Genentech) for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body. Phesgo also treats adult patients with early HER2-positive breast cancer.

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“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 the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a press release.

“As part of the 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,” Pazdur added. “At this critical time, we continue to expedite oncology product development. This application was approved about four months ahead of the FDA goal date.”

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

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Prescribing information for Phesgo includes a boxed warning to advise health care professionals and patients about the risk of potential heart failure, fetal harm and lung toxicity. Health care professionals should use similar monitoring parameters as those used with IV pertuzumab and IV trastuzumab, FDA said.

FDA also approved pembrolizumab (Keytruda, Merck & Co.) for IV injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

“This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy,” FDA said in a press release.

“Metastatic colorectal cancer is a serious and life-threatening disease with a poor prognosis. Available current therapy with chemotherapy combinations and other biologics are associated with substantial toxicity. Having a non-chemotherapy option available for selected patients is a noteworthy paradigm shift in treatment,” Pazdur said.

FDA’s approval was based on the results of one multicenter, international, open-label, active-controlled, randomized trial that compared Keytruda with chemotherapy treatment in 307 patients with MSI-H or dMMR metastatic colorectal cancer. The study demonstrated a statistically significant improvement in progression-free survival (PFS): median PFS was 16.5 months in the Keytruda group and 8.2 months in the standard of care group, FDA said.

“Longer-term analysis is needed to assess for an effect on survival,” the agency added.

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