Drugs

FDA OKs Trodelvy for Triple-negative Breast Cancer

FDA has approved an Immunomedics BLA for Trodelvy (sacituzumab govitecan-hziy) for treating adult patients with triple-negative metastatic breast cancer. The agency says that patients must have received at least two prior therapies before taking Trodelvy. The accelerated approval was granted one month ahead of its user fee review action target date.

The Trop-2-directed antibody and topoisomerase inhibitor drug conjugate “targets the Trop-2 receptor that helps the cancer grow, divide and spread, and is linked to topoisomerase inhibitor, which is a chemical compound that is toxic to cancer cells,” the agency say. About 20% of breast cancer diagnoses worldwide are triple-negative, meaning the cancer tests negative for estrogen receptors, progesterone receptors and human epidermal growth factor receptor 2 (HER2) protein. “Therefore, triple-negative breast cancer does not respond to hormonal therapy medicines or medicines that target HER2,” it says.

Approval was based on data from a clinical trial involving 108 patients with metastatic triple-negative breast cancer who had received at least two prior treatments for metastatic disease. In the trial, the overall response rate was 33.3%, with a median duration of response of 7.7 months. “Of the patients with a response to Trodelvy, 55.6% maintained their response for six or more months and 16.7% maintained their response for 12 or more months,” FDA says. The approval also requires a Boxed Warning to advise health care professionals and patients about the risk of severe neutropenia and severe diarrhea. “Health care professionals should monitor patient’s blood cell counts periodically during treatment with Trodelvy and consider treatment with a type of therapy called granulocyte-colony stimulating factor (G-CSF), which stimulates the bone marrow to produce white blood cells called granulocytes and stem cells and releases them into the bloodstream, to help prevent infection, and should initiate anti-infective treatment in patients with febrile neutropenia (development of fever when white blood cell are abnormally low),” it adds.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome