Drugs

FDA Approves Faslodex/Palbociclib Combo Use in Cancer

FDA has approved an expanded indication for AstraZeneca’s Faslodex (fulvestrant), for combination use with palbociclib in treating women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy. Single-therapy Faslodex has been approved since 2002 for treating postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy. “We believe that advances in cancer treatment will come, in part, from our research building upon existing treatments,” the company says.

Approval was based on data from the Phase 3 PALOMA-3 trial, which met the study’s primary endpoint of progression-free survival (PFS). “The combination of FASLODEX 500 mg and palbociclib 125 mg resulted in a 4.9 month PFS improvement over FASLODEX and placebo, in women with HR+ HER2- advanced or MBC whose disease had progressed after endocrine therapy,” according to the company. “Improvement in PFS was seen irrespective of menopausal status.”

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