Drugs

Array Gains SPA for Colon Cancer Therapy

Array BioPharma has reached agreement with FDA on a special protocol assessment (SPA) for BEACON CRC, a global Phase 3 trial involving encorafenib and Erbitux (cetuximab), with or without binimetinib, versus standard of care in patients with BRAF-mutant colorectal cancer (CRC) who have previously received first-or second-line systemic therapy. “The SPA provides agreement that the design and planned analysis of BEACON CRC adequately address the objectives necessary to support a regulatory submission for the approval of the doublet regimen of encorafenib and Erbitux,” the company says. The agency also told Array that data from the study showing the triple regimen (encorafenib, Erbitux and binimetinib) both met its primary endpoint (overall survival) as compared to the control arm, and demonstrated a clinically meaningful benefit as compared to the double regimen, would provide support for approval, the company says.

The study is designed to enroll 615 patients who will be randomized 1:1:1 to receive triple therapy (encorafenib, Erbitux and binimetinib), double therapy (encorafenib and Erbitux) or the control arm (irinotecan-based therapy and Erbitux), Array says. The primary endpoint of the trial is overall survival when comparing the triple therapy to the control arm. Secondary endpoints address efficacy of the double therapy compared to the control arm, and the triple therapy compared to the doublet therapy.

Array is conducting BEACON CRC in partnership with Pierre Fabre and Merck KGaA. Binimetinib is a late-stage small molecule MEK inhibitor and encorafenib is a late-stage small molecule BRAF inhibitor, both of which target key enzymes in the MAPK signaling pathway, the company says. This pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis.

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