Drugs

Caris’ Companion Diagnostic for Cancer Approved

FDA has approved Caris Life Sciences’ MI Cancer Seek and its use as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies. “The assay includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies,” the company says. “MI Cancer Seek is the first and only simultaneous whole exome sequencing (WES) and whole transcriptome sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors,” it says.

The next-generation sequencing-based in vitro diagnostic device uses total nucleic acid isolated from formalin-fixed paraffin-embedded tumor tissue specimens to identify patients who may benefit from treatment with the following targeted therapies:

Piqray (alpelisib) for breast cancer
Vectibix (panitumumab) for colorectal cancer
Braftovi (encorafenib) in combination with Erbitux (cetuximab) for colorectal cancer
BRAF Inhibitors approved by FDA for melanoma
Mekinist (trametinib) or BRAF/MEK inhibitor combinations approved by FDA for melanoma
EGFR tyrosine kinase inhibitors approved by FDA for lung cancer
Keytruda (pembrolizumab), Jemperli (dostarlimab-gxly) for solid tumors
Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for endometrial carcinoma

Additionally, the company says MI Cancer Seek is intended to “provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.”

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