Drugs

Pfizer sNDA Expands Ibrance for Male Breast Cancer

FDA has approved a Pfizer supplemental NDA for Ibrance (palbociclib) capsules and their use in combination with specific endocrine therapies for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in male patients. The drug was initially approved in 2015 for treating certain women with breast cancer.

The expanded indication was approved based on data from postmarketing reports and electronic health records “showing that the safety profile for men treated with Ibrance is consistent with the safety profile in women treated with Ibrance,” an FDA release says. “Some approved indications for breast cancer treatments do not distinguish by gender, but in certain cases if there is a concern that there may be a difference in efficacy or safety results between men and women, then further data may be necessary to support a labeling indication for male patients.”

The agency says that the most common side effects observed in studies were infections, leukopenia, fatigue, nausea, stomatitis, anemia, hair loss, diarrhea and thrombocytopenia. “Because of the potential for genotoxicity (damage to cells), health care providers are advised to tell male patients with female partners of reproductive potential to use effective contraception during treatment with Ibrance and for three months after the last dose,” it says.

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