Drugs

Corcept’s Lifyorli Combo in Platinum-Resistant Ovarian Cancer Approved

FDA has approved Corcept Therapeutics’s cortisol-modulating drug Lifyorli (relacorilant) in combination with nab-paclitaxel for patients with platinum-resistant ovarian cancer.

The action is backed by data from the Phase 3 ROSELLA trial, where the combo delivered a statistically significant overall survival benefit — a relatively rare outcome in this hard-to-treat setting. Patients receiving Lifyorli plus chemotherapy saw a 35% reduction in the risk of death compared to nab-paclitaxel alone, translating to a median overall survival of 16.0 months versus 11.9 months, according to the company. The study also hit its second primary endpoint, showing a 30% reduction in the risk of disease progression.

The approval positions Lifyorli as the first selective glucocorticoid receptor antagonist approved by the agency, marking a novel approach that targets cortisol signaling — a pathway Corcept has long argued contributes to tumor resistance by dampening apoptosis and immune response. Notably, the ROSELLA trial did not require biomarker selection, which could simplify uptake in clinical practice compared to more targeted therapies.

Regarding safety, the drug’s label includes warnings for neutropenia, infections and adrenal insufficiency, while the most common side effects included hematologic toxicities, fatigue and gastrointestinal symptoms, according to the company.

The approval covers adults with platinum-resistant ovarian cancer, as well as related fallopian tube and primary peritoneal cancers, who have received one to three prior lines of therapy including bevacizumab — a population with limited treatment options and poor prognosis.

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