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Trodelvy (Sacituzumab Govitecan) for Metastatic Triple Negative Breast Cancer

Writer's picture: Surviving Breast CancerSurviving Breast Cancer

By Abigail Johnston


Disclaimer: This post is not intended to be taken or received as medical advice nor is the author able to offer medical advice. Each patient who is interested in medication or statements made herein should consult with a qualified medical professional to learn more.

Trodelvy Approval

On April 22, 2020, the FDA approved sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease, so it would be the third line of treatment for those living with mTNBC. Trodelvy (try saying that 5 times fast) is the first antibody-drug conjugate approved by the FDA specifically for metastatic triple-negative metastatic breast cancer. It is also the first FDA-approved anti–Trop-2 antibody-drug conjugate. If that sounds like another language, it really is. The bottom line is that this new medication represents a significant step forward in the treatment of mTNBC, a diagnosis that often carries a very grim prognosis and, until recently, has lagged behind the other subtypes in terms of available treatments outside of traditional chemotherapy.


As of December 2020, Gilead released new data from the ASCENT trial that continues to show promising results of Trodelvy for patients with mTNBC. Gilead has submitted a Biologics License Application (sBLA) to the Food and Drug Administration (FDA) to receive full approval for Trodelvy as a treatment option for adult patients with mTNBC who have received at least two prior therapies.


Trodelvy and Metastatic Triple-Negative Breast Cancer

“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 sacituzumab govitecan-hziy represents a new targeted therapy for patients living with this aggressive malignancy,” 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. “There is intense interest in finding new medications to help treat metastatic triple-negative breast cancer. [This] approval provides patients who’ve already tried two prior therapies with a new option.” For more information from ASCO (American Society of Clinical Oncologists), you can read more here.


ASCENT Trial

The trial (ASCENT) that led to the approval by the FDA in May of 2020 enrolled 108 patients (a BIG thank you to those brave souls) who had undergone a range of 2-10 prior treatments for metastatic disease. The medication (10mg/kg) is an injection administered twice in a 21-day period. From my review of the study, The overall response rate was 33.3% (95% confidence interval [CI] = 24.6%–43.1%), with a median duration of response of 7.7 months (95% CI = 4.9–10.8). Of the patients with a response to sacituzumab govitecan-hziy, 55.6% maintained their response for 6 or more months and 16.7% maintained their response for 12 or more months.”


Trodelvy Side Effects