Drugs

FDA Approves AstraZeneca’s Lynparza for Expanded Use

FDA has approved an AstraZeneca NDA for Lynparza (olaparib) and its use as a maintenance treatment in adults with recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status. The approval also covers the use of Lynparza tablets (two tablets twice daily) as opposed to capsules (eight capsules twice daily). And it converts the product’s 2014 accelerated approval to full approval for treating adult patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer.

The approvals are based on data from two clinical trials. SOLO-2 confirmed the benefit of Lynparza in germline BRCA-mutated patients, demonstrating a 70% reduced risk of disease progression or death and improved median progression-free survival (PFS) to 19.1 vs 5.5 months for placebo, according to the company. Study 19 showed that Lynparza reduced the risk of disease progression or death by 65% and improved PFS compared with placebo in patients of any BRCA status (median PFS of 8.4 months with Lynparza vs 4.8 months with placebo).

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