Drugs

Epizyme Tazemetostat NDA Filed for Epithelioid Sarcoma

Epizyme has submitted an NDA seeking accelerated approval of tazemetostat for treating patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. The company describes Tazemetostat is an oral, first-in-class, EZH2 inhibitor that it discovered and is developing for various cancers and treatment settings.

The submission is based on updated tazemetostat efficacy and safety data from 62 patients enrolled in the epithelioid sarcoma cohort of a Phase 2 clinical trial, which will be reported in an oral presentation at the American Society of Clinical Oncology 2019 annual meeting, according to the company. To support full approval, Epizyme says it plans to conduct a global, randomized, controlled trial, that it expects to begin shortly.

Epithelioid sarcoma is an ultra-rare soft tissue sarcoma characterized by a loss of the protein INI1, Epizyme says. Patients are most commonly diagnosed as young adults, between 20 and 40 years of age, and median overall survival from initial diagnosis is 30 months.

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