FDA approves Immunomedics’ Trodelvy for metastatic triple-negative breast cancer one month ahead of schedule

pharmafile | April 23, 2020 | News story | Sales and Marketing Cancer, Immunomedics, Trodelvy, breast cancer, pharma 

Immunomedics has scored approval with the FDA for Trodelvy (sacituzumab govitecan-hziy) in the treatment of metastatic triple-negative breast cancer, it has emerged.

The US regulator granted the drug accelerated approval, and this authorisation was secured through the FDA’s Priority Review and Breakthrough Therapy designation. It concerns adult patients, and they must have received at least two prior therapies to be eligible to receive Trodelvy.

The approval was picked up on the back of data in 108 patients, where the drug scored a 33% overall response rate, and a median duration of response of 7.7 months. Furthermore, 55.6% of responding patients maintained that response for at least six months, while 16.7% maintained their response for a full year or more.

“Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options. Chemotherapy has been the mainstay of treatment for triple-negative breast cancer. The approval of Trodelvy today represents a new targeted therapy for patients living with this aggressive malignancy,” commented Dr Richard Pazdur, 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. “There is intense interest in finding new medications to help treat metastatic triple-negative breast cancer. Today’s approval provides patients who’ve already tried two prior therapies with a new option.”

It is important to mention that prescribing info for the drug includes a boxed warning of the risks of severe neutropenia and severe diarrhoea associated with its use, with the manufacturer noting that treatment may need to be withheld, reduced or permanently discontinued in the event of these ailments.

The FDA was keen to use this approval to demonstrate its efficiency and priorities under the strain of the COVID-19 pandemic. Dr Pazdur explained: “As part of FDA’s ongoing and aggressive 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 more than a month ahead of the FDA goal date – an example of that commitment. 

Matt Fellows

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