Drugs

Trodelvy OK’d for First-Line Triple-Negative Breast Cancer

FDA has approved Gilead Sciences' antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) for first-line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC), significantly expanding the drug's role in one of the most aggressive forms of breast cancer. The approval covers Trodelvy’s use as a monotherapy in patients who are not candidates for PD-1 or PD-L1 inhibitor-based treatment and in combination with Merck's Keytruda (pembrolizumab) for patients whose tumors express PD-L1, defined as a combined positive score (CPS) of 10 or greater using an FDA-authorized diagnostic test.

The decision was supported by data from the Phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19 studies, which demonstrated statistically significant improvements in progression-free survival compared with chemotherapy-based regimens, according to the company.

In ASCENT-03, Gilead says Trodelvy monotherapy reduced the risk of disease progression or death by 38% compared with chemotherapy in patients whose disease was not eligible for PD-L1-directed treatment. In ASCENT-04, the combination of Trodelvy and pembrolizumab reduced the risk of progression or death by 35% compared with pembrolizumab plus chemotherapy in patients with PD-L1-positive tumors.

The studies also showed more durable responses with Trodelvy-based regimens, according to the company. Median duration of response reached 12.2 months versus 7.2 months with chemotherapy in ASCENT-03, while patients receiving Trodelvy plus pembrolizumab in ASCENT-04 achieved a median duration of response of 16.5 months compared with 9.2 months for the chemotherapy-containing comparator arm.

Trodelvy, a Trop-2-directed ADC, was previously approved for patients with metastatic triple-negative breast cancer who had received two or more prior systemic therapies and for certain patients with hormone receptor-positive, HER2-negative metastatic breast cancer. With the new indication, the drug moves into the front-line treatment setting, where more than half of patients with metastatic TNBC do not go on to receive subsequent therapies.

The approval comes as ADCs continue to reshape treatment paradigms across multiple solid tumors. Trodelvy is currently being evaluated in several ongoing Phase 3 studies in breast, lung and gynecologic cancers, including earlier-stage disease settings and combination regimens.

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

Read more

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