Clinical Gilead’s Trodelvy Bags FDA Green Light For Metastatic Breast...

Gilead’s Trodelvy Bags FDA Green Light For Metastatic Breast Cancer


The Food and Drug Administration (FDA) has given the nod to Gilead Sciences’ drug Trodelvy for the treatment of individuals suffering from hormone receptor (HR)-positive, HER2-negative breast cancer that can no longer be fixed through surgical resection.

Patients must have already attempted endocrine treatment in addition to two other treatments in the metastatic context before being considered for the therapy.

“Despite decades of advances, people living with pretreated HR-positive, HER2-negative metastatic breast cancer need new treatment options,” stated Dr. Hope S. Rugo, a medical oncologist and hematologist concentrating on breast cancer research and treatment. “Nearly all people with this type of breast cancer will eventually develop resistance to endocrine-based therapies and progress on available chemotherapies.”

Trodelvy was already permitted to address triple-negative breast cancer before Friday’s decision. However, nearly 70% of all breast cancer cases involve women with HR-positive, HER2-negative illnesses – a much bigger patient group.

Trodelvy sales might be substantially increased if it were to get a significant market share in HR-positive, HER-2-negative breast cancer. However, the prospect has been clouded by a recent market change, which was spearheaded by AstraZeneca and Daiichi Sankyo’s Enhertu.

Trodelvy must achieve a minimum of $4 billion in sales for Gilead’s investment of $21 billion to acquire Trodelvy producer Immunomedics to be worthwhile. RBC experts predict that the drug’s pretreatment HR+/HER2- indication might yield $1.1 billion in sales. The team reached that forecast based on Gilead’s presentation of patient survival statistics from the phase 3 TROPiCS-02 study.

In the trial, there were patients with HR-positive, HER2-negative breast cancer whose illness did not react to or ceased reacting to previous therapy. It compared Trodelvy to the treatment of the doctor’s choosing.

The mean progression-free survival, which is measured as the amount of time from therapy until the illness worsens or progresses, was 6.4 months in the Trodelvy cohort and 4.2 months in the group receiving treatment of the doctor’s choice.

Trodelvy initially fell short in its capacity to halt tumor development or death. Soon after, Enhertu, a HER2-directed ADC, presented findings that revolutionized clinical practice by reducing the risk of progress or fatality against chemotherapy in patients who had previously received chemo by 50% and the risk of death against chemotherapy by 36%, respectively, in the newly defined breast cancer subtype known as HER2-low.

Fortunately for Gilead, Trodelvy eventually returned with a more impressive overall survival victory. In comparison to chemo, Trodelvy therapy resulted in a 21% lower risk of mortality after a prolonged follow-up of TROPiCS-02. According to doctors questioned by RBC, Trodelvy also increased patients’ median overall survival by over 3 months, passing a clinical relevance test. 

However, there is overlap between Enhertu and Trodelvy’s target groups because HER2-low patients were earlier included in the HER2-negative category. Enhertu’s study included patients who were receiving an earlier course of therapy, but the drug’s effectiveness results were so striking that they essentially stole Trodelvy’s limelight.

Still, breast cancer treatments require more treatment options, according to Rugo. She stated that the lack of available treatments contributes to the death of many breast cancer patients, which makes Trodelvy’s victory excellent news for the industry.

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