Drugs

AbbVie Seeks Accelerated OK for Lung Cancer Drug

AbbVie says it will engage with FDA about filing for accelerated approval of telisotuzumab-vedotin (Teliso-V) in patients with c-Met protein overexpression, epidermal growth factor receptor wild type, advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC). The decision to seek accelerated approval is based on just-announced topline results from the single-arm Phase 2 LUMINOSITY trial that demonstrated a “compelling overall response rate per independent central review (ICR) of 35% and 23% across c-Met High and c-Met Intermediate patients respectively,” the company says.

Teliso-V is described as an investigational first-in-class c-Met protein-directed antibody-drug conjugate targeting patients with c-Met overexpressing tumors. “C-Met is a receptor tyrosine kinase that is overexpressed in many solid tumors including NSCLC,” the company says.

Abbvie says that other endpoints demonstrated meaningful clinical outcomes including median duration of response of 9 months and 7.2 months, and a median overall survival of 14.6 months and 14.2 months in c-Met High and c-Met Intermediate patients respectively.

Regarding safety, the company says Teliso-V’s safety profile was consistent with previous findings and no new safety concerns were identified in the LUMINOSITY trial. “Adverse events with Teliso-V monotherapy were generally well managed and tolerated,” it says.

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