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MDx/CDx Focus: CHMP Recommends Mekinist; Biocept Launches Biomarker Research Services for Pharma


UK's CHMP Grants Positive Review of MEK Inhibitor Melanoma Drug Mekinist

The UK's Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission grant marketing authorization to GlaxoSmithKline's Mekinist (trametinib).

"The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Mekinist and therefore recommends the granting of the marketing authorization," the committee said in a statement.

The drug is a MEK inhibitor indicated for treatment of patients with unresectable or metastatic melanoma, whose tumors have a BRAF V600 mutation. "The benefits with Mekinist are its ability to improve overall survival and progression free survival in melanoma patients with a BRAF V600 mutation compared to chemotherapy," CHMP said in a release announcing its decision.

The US Food and Drug Administration approved Mekinist, along with another GSK BRAF inhibitor Tafinlar (dabrafenib), last year. The FDA then this year greenlighted the combination of the two agents as a treatment for metastatic melanoma patients with BRAF mutations. Although GSK developed Mekinist, under a recent strategic deal, the company granted Novartis rights to its oncology portfolio, including this drug (see related story, in this issue).

GSK, under a partnership with Biomerieux, advanced a companion test for Mekinist and Tafinlar that gauges whether patients harbor BRAF mutations that make them more likely to respond to the drugs.

As part of the marketing strategy for Mekinist, CHMP has asked the drug sponsor to implement a pharmacovigilance plan for the drug.

Biocept Launches CTC-based Biomarker Research Service for Pharma Companies

Biocept has launched blood-based biomarker testing services aimed at helping pharmaceutical clients identify the right patients for their investigational targeted treatments.

The company specializes in gauging tumor DNA biomarkers from circulating tumor cells and cell-free circulating tumor DNA from plasma. The company will perform testing in its CLIA-certified, CAP-accredited lab. Among the markers that Biocept can gauge from CTCs, include ALK and ROS1 translocations in non-small cell; MET copy number analysis in NSCLC and gastrointestinal cancers; HER2 copy number analysis in breast and GI cancers; ER protein expression in breast cancer; and AR, PTEN, and MYC copy number and loss of gene region in prostate cancer. Additionally, the company can use cell-free tumor DNA to conduct EGFR mutational analysis in NSCLC and KRAS mutational analysis in NSCLC and colon cancers.

"In addition to these assays, Biocept will offer key tumor activating mutation and resistance marker analysis in blood samples for use when tissue based biopsy samples may not be feasible," the company said in a statement.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.