Drugs

Roche Ventana ALK Assay Approved by FDA

FDA has approved a Roche PMA for the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer patients eligible for treatment with Genentech’s (a Roche subsidiary) Alecensa (alectinib). Alecensa gained approval 11/7 based on data from the Phase 3 ALEX study, which showed the drug reduced the risk of disease worsening or death (progression-free survival) by 47% compared to crizotinib (Pfizer’s Xalkori) as assessed by an independent review committee. Median progression-free survival was 25.7 months for those taking Alecensa compared with 10.4 months for those who received crizotinib. The study also showed that Alecensa significantly reduced the risk of the cancer spreading to the brain or central nervous system compared to crizotinib.

Roche says the Ventana assay has been shown in studies to identify more patients that will benefit from an anti-ALK target therapy than fluorescent in situ hybridization (FISH) testing. It is available for use on the Roche BenchMark XT or BenchMark ULTRA IHC/FISH slide staining systems.

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