Drugs

Advisors Asked About Olaparib sNDA Population

FDA is asking the Oncologic Drugs Advisory Committee (ODAC) to discuss whether an sNDA for AstraZeneca’s olaparib (Lynparza) should be restricted to selected patients. An agency briefing document released in advance of the 4/28 ODAC meeting says AZ is seeking a broad indication for olaparib in combination with abiraterone (Janssen’s Zytiga) as first-line therapy for patients with metastatic castration-resistant prostate cancer unselected for the presence of BRCA or HRR mutations.

The medical reviewers say in the briefing document that in the PROpel trial evaluating the combination, patients were enrolled regardless of BRCA or HRR mutation status.

“Despite lack of stratification and pre-specified analyses by biomarker,” the reviewers write, “exploratory subgroup analyses demonstrate that efficacy is largely attributable to patients with tumor BRAC mutations, with modest benefit and possible harm for patients without tumor BRAC mutations.”

The document also says FDA is concerned about the added toxicity in patients without BRCA mutations, particularly in an add-on treatment setting where the median duration of rPFS (radiographic progression-free survival) with abiraterone by itself is approximately 16 months. “FDA is therefore concerned that olaparib may represent a toxic placebo in patients without tumor BRCA mutations,” the document 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