FDA to Speed Up Review of Trodelvy for HR-Positive, HER2-Negative Metastatic Breast Cancer

The Food and Drug Administration granted a priority review to Trodelvy for previously treated locally advanced or metastatic HR-positive, HER2-negative breast cancer.

The Food and Drug Administration (FDA) granted a priority review for a supplemental Biologics License Application for Trodelvy (sacituzumab govitecan-hziy) to treat adults with unresectable locally advanced or metastatic (having spread to different parts of the body) HR-positive, HER2-negative breast cancer that has previously been treated with endocrine therapy and at least two other systemic therapies for metastatic disease, according to Gilead, the manufacturer of the drug.

The FDA grants priority reviews to drugs that could offer a specific patient population the potential for improved outcomes over the current standard of care. Once a therapy gets a priority review, the FDA works closely with the pharmaceutical company to expedite the development and review of the agent.

The FDA plans on making its approval decision on Trodelvy for this patient population in February 2023, though it is possible that this date be moved up or pushed back.

The priority review is based off findings from the phase 3 TROPiCS-02 clinical trial, which showed that Trodelvy led to a 34% risk reduction for disease progression or death compared to physician’s choice of chemotherapy (eribulin, capecitabine, gemcitabine or vinorelbine). On average, patients in the Trodelvy group lived for 5.5 months before their disease worsened (a statistic known as progression-free survival), compared to four months for those receiving chemotherapy.

Study findings also showed that Trodelvy reduced the overall risk of death by 21% compared to chemotherapy. Patients in the Trodelvy group lived for an average of 14.4 months after receiving treatment, compared to 11.2 months for those administered chemotherapy.

The current five-year survival rate for metastatic HR-positive, HER2-negative breast cancer is 30%, according to Gilead, and once a patient’s disease stops responding to endocrine therapy, chemotherapy is typically the only treatment option left.

Of note, Trodelvy comes with a Boxed Warning (a serious note of caution from the FDA that must be displayed on the drug’s packaging) for severe neutropenia and diarrhea.


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