gdc
Breast CancerFDA Approvals, News & Updates

Trodelvy New Therapy Approved for Triple-Negative Breast Cancer

In April, 2020, the FDA approved Trodelvy for the treatment of adults with metastatic triple-negative breast cancer after 2 or more previous therapies.
June 2020 Vol 6 No 3

On April 22, 2020, the FDA approved Trodelvy (sacituzumab govitecan-hziy; from Immunomedics) for the treatment of adults with metastatic (spreading) triple-negative breast cancer, or TNBC, after at least 2 previous therapies.

“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,” said Richard Pazdur, M.D., Director of the FDA’s Oncology Center of Excellence.

Trodelvy is a Trop-2–directed antibody and topoi­somerase inhibitor drug conjugate, meaning that the drug targets the Trop-2 receptor that promotes the growth and spread of cancer cells, and it is linked to a topoisomerase inhibitor, which kills cancer cells.

About 20% of patients with breast cancers have triple-negative breast cancer, meaning they don’t have any of the 3 biomarkers often seen in breast cancer, including estrogen receptor (or ER), progesterone receptor (or PR), and HER2. Therefore, triple-­negative breast cancer doesn’t respond to hormone therapies that target ER, PR, or HER2.

Among the 108 patients included in the clinical trial that led to the FDA approval of Trodelvy, the tumor was shrinking in response to therapy with Trodelvy in about one-third (33%) of the patients. The average duration of the response was 7.7 months, ranging from 6 months to more than 12 months.

The most common side effects with Trodelvy were nausea, neutropenia (reduced white blood cells), diarrhea, fatigue, anemia, vomiting, hair loss, constipation, decreased appetite, rash, and abdominal pain.

Recommended For You
BiomarkersBreast CancerSurvivorship
Surviving Pregnancy and Breast Cancer
By Kelsey Moroz
With her family history of cancers related to the BRCA mutation, Jamie Ledezma’s first pregnancy suddenly got very complicated when she learned she had triple-negative breast cancer.
BiomarkersFDA Approvals, News & Updates
Tabrecta Approved for NSCLC with MET Biomarker

On May 6, 2020, the FDA approved Tabrecta (capmatinib; from Novartis), an oral kinase inhibitor, for adults with metastatic (spreading) non–small-cell lung cancer (NSCLC).

FDA Approvals, News & UpdatesLeukemia
First-Line Treatment with Calquence Produces Long-Term Responses in Patients with Chronic Lymphocytic Leukemia
By Dana Taylor
The FDA approved a new Bruton tyrosine kinase (or BTK), Calquence, for first-line treatment of patients with CLL.
FDA Approvals, News & UpdatesOvarian Cancer
Zejula Now Approved as First-Line Maintenance Therapy in All Patients with Ovarian Cancer
In April 2020, the FDA approved Zejula for long-term maintenance therapy for all patients with advanced ovarian cancer, regardless of any gene mutations.
Last modified: June 29, 2020

Subscribe to CONQUER: the patient voice magazine

Receive timely cancer news & updates, patient stories, and more.

Country