Drugs

FDA Approves Takeda’s Exkivity for Some Lung Cancers

FDA has approved Takeda’s Exkivity (mobocertinib) to treat adults with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) Exon20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The company says Exkivity is the only approved oral therapy specifically designed to target EGFR Exon20 insertion mutations.

Exkivity was granted priority review and received breakthrough therapy designation, fast track designation, and orphan drug designation, and was granted accelerated approval.

FDA simultaneously approved Thermo Fisher Scientific’s Oncomine Dx Target Test as a next-generation sequencing companion diagnostic to identify patients with EGFR Exon20 insertions.

The agency approval of Exkivity was based on results from the platinum-pretreated population in a Phase 1/2 trial that involved 114 patients. The most common adverse reactions were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. The drug labeling includes a Boxed Warning for QTc prolongation and Torsades de Pointes, and Warnings and Precautions for interstitial lung disease/pneumonitis, cardiac toxicity, and diarrhea.

The FDA review was conducted under the FDA Oncology Center of Excellence Project Orbis.

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