EIRs/483s

FDA Expands Ibrance for Breast Cancer Maintenance

FDA has granted Pfizer expanded approval for Ibrance in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with hormone receptor (HR)-positive, HER2-positive locally advanced or metastatic breast cancer following induction therapy. The 6/24 approval expands the use of the CDK4/6 inhibitor into a subset of breast cancer patients who have not experienced disease progression after initial treatment with a taxane and HER2-targeted therapy, according to an FDA release.

The approval was based on results from the Phase 3 PATINA trial, which enrolled 518 patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer. Participants who remained progression-free following induction treatment with a taxane and trastuzumab, with or without pertuzumab, were randomized to receive either palbociclib plus anti-HER2 therapy and endocrine therapy or anti-HER2 therapy and endocrine therapy alone.

FDA said the study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival for patients receiving the palbociclib-containing regimen. The treatment reduced the risk of disease progression or death by 24% compared with the control arm.

Median progression-free survival could not be adequately estimated because of censoring in the dataset, according to the agency. Overall survival data remain immature.

The approval marks one of the first CDK4/6 inhibitor indications in the HER2-positive metastatic breast cancer maintenance setting, an area where treatment has traditionally relied on HER2-targeted therapies and endocrine therapy following chemotherapy.

The approved regimen allows physicians to combine palbociclib with trastuzumab and endocrine therapy, with the option of continuing pertuzumab when appropriate. Endocrine therapy options in the trial included fulvestrant or an aromatase inhibitor, such as anastrozole, letrozole, or exemestane.

Ibrance's prescribing information includes warnings for neutropenia, interstitial lung disease and pneumonitis, and embryo-fetal toxicity.

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