Drugs

Roche Breast Cancer Drug Misses Endpoint in Late-Stage Trial

Roche is reporting that its investigational breast cancer drug giredestrant failed to significantly extend progression-free survival in a Phase 3 study when combined with the CDK4/6 inhibitor palbociclib (Pfizer’s Ibrance), dealing a setback to the company’s effort to establish the therapy in first-line metastatic disease.

The persevERA Breast Cancer trial tested the oral selective estrogen receptor degrader against the standard endocrine therapy regimen of letrozole plus palbociclib in patients with estrogen receptor–positive, HER2-negative locally advanced or metastatic breast cancer. The study did not meet its primary endpoint of a statistically significant improvement in investigator-assessed progression-free survival in the overall population, though Roche said the combination showed a numerical improvement.

Safety findings for the giredestrant regimen were consistent with the known profiles of the individual drugs and adverse events were considered manageable, the company said.

“While persevERA didn’t meet its primary objective, we are confident in the potential of giredestrant to become a new standard-of-care endocrine therapy in early and advanced ER-positive breast cancer,” a Roche release says. Despite the negative primary outcome, Roche says it plans to continue advancing the drug across multiple clinical settings.

Giredestrant is a next-generation oral selective estrogen receptor degrader designed to block estrogen signaling and trigger degradation of the estrogen receptor, a driver of tumor growth in many breast cancers.

Last month, FDA accepted for review a Roche/Genentech NDA for giredestrant and its use in combination with everolimus for adults with estrogen receptor-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer that has recurred or progressed following prior endocrine-based therapy. The agency has set a user fee review action target date of 12/18.

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