Drugs

FDA Reviewers Question Spectrum’s Pozenveo

FDA medical reviewers have raised significant questions in advance of a 9/22 meeting of the agency’s Oncologic Drugs Advisory Committee to consider Spectrum Pharmaceuticals’ application for accelerated approval of Pozenveo (poziotinib) to treat patients with previously treated locally advanced or metastatic non-small cell lung cancer harboring human epidermal growth factor receptor 2 exon 20 insertion mutations. In a committee briefing document, reviewers say their concerns are:

low overall response rate (28%) with minimal duration of response (median of 5.1 months);
poorly tolerated safety profile at the currently proposed dosage; and
inadequate dosage optimization throughout the development program.

The reviewers said the rate of interruptions and dose reductions may be mitigated in patients receiving alternative doses. They also said Spectrum is proposing two different doses for accelerated approval (16 mg once daily) and the planned confirmatory trial (8 mg twice daily) and noted that confirmation of benefit will be significantly delayed given that the confirmatory trial has not begun enrolling patients.

Advisory committee members are being asked to discuss issues involving efficacy, safety, dosage optimization, and the confirmatory trial. The reviewers say that if the drug is granted accelerated approval, it would be the least effective targeted therapy for lung cancer approved to date.

“Given the concerns regarding marginal efficacy in the face of high rates of toxicity, poor tolerability, lack of dosage optimization, and significant delay in confirmation of benefit,” the reviewers conclude, “FDA requests discussion on the overall risk-benefit assessment of this application.”

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