Drugs

AstraZeneca Breast Cancer NDA Review Extended by FDA

FDA has extended its review of an AstraZeneca NDA for camizestrant, an experimental breast cancer therapy, after requesting additional data tied to a closely watched Phase 3 study that has drawn scrutiny from outside advisers. The company is seeking approval for camizestrant in combination with CDK4/6 inhibitors for first-line treatment of patients with hormone receptor-positive, HER2-negative advanced breast cancer whose tumors develop ESR1 mutations.

AstraZeneca did not disclose the original or new user fee review action target date. Generally, such extensions are three months and likely push the review action to late August or early September.

The filing is based on results from the pivotal SERENA-6 Phase 3 trial, which evaluated whether switching patients from standard endocrine therapy to camizestrant after detection of ESR1 mutations in circulating tumor DNA, but before radiographic disease progression, could improve outcomes.

The regulatory delay follows a contentious April advisory committee meeting, where panelists failed to reach a majority vote supporting the benefit of the treatment-switch strategy evaluated in SERENA-6.

Following the meeting, AstraZeneca submitted additional analyses requested by FDA, including data on circulating tumor DNA clearance and its relationship to longer-term efficacy outcomes. The company says those results will be presented 6/2 at the annual meeting of the American Society of Clinical Oncology.

“We are committed to continuously advancing the clinical landscape in oncology in pursuit of improving outcomes for patients,” a company statement says. “The SERENA-6 treatment strategy epitomises this approach by monitoring patients for the emergence of ESR1 mutations in ctDNA and testing if a switch of endocrine backbone therapy at this point improves outcomes.”

Hormone receptor-positive, HER2-negative disease is the most common subtype of breast cancer, accounting for roughly 70% of cases. Resistance to endocrine therapy remains a major challenge, particularly when tumors acquire ESR1 mutations, which are associated with poorer outcomes and commonly emerge during first-line treatment.

Camizestrant is an investigational oral selective estrogen receptor degrader, or SERD, designed to block and degrade estrogen receptors that drive tumor growth. AstraZeneca is studying the drug across several late-stage breast cancer trials, including SERENA-4, CAMBRIA-1 and CAMBRIA-2.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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