Drugs

AbbVie Gains Rare Pediatric Disease Status for Brain Tumor Drug

FDA has granted AbbVie a rare pediatric disease designation for ABT-414, an investigational antibody drug conjugate targeting the epidermal growth factor receptor (EGFR) for treating pediatric patients with EGFR-amplified diffuse intrinsic pontine glioma (DIPG). The highly aggressive and difficult to treat brain tumors are found at the base of the brain.^“Though brainstem tumors are extremely rare among adults, they comprise approximately 10-15% of all pediatric brain tumors,” the company says. DIPG is the most common subtype of tumor in this anatomical region and the second most common childhood malignant brain tumor.

The designation was based on a proposed pediatric sub-study “nested” within an ongoing Phase 2 study of ABT-414 in adults with recurrent EGFR-amplified glioblastoma, conducted in collaboration with the European Organization for Research and Treatment of Cancer, AbbVie says. In 2014, the investigational monoclonal antibody drug conjugate was given an orphan drug designation for treating adult glioblastoma and glioma.

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