UPDATE 1-EU Agency Backs Approval of New GlaxoSmithKline Melanoma Drug

“GlaxoSmithKline’s melanoma drug Mekinist – one of several drugs being sold to Novartis under an asset swap deal – has been recommended for approval by European regulators.

“The European Medicines Agency (EMA) said on Friday its experts had backed the drug, also known as trametinib, as a treatment for unresectable or metastatic melanoma in patients with a mutation of a gene known as BRAF.”

Watchdog approves skin cancer drugs ipilimumab and vemurafenib

Patients with an advanced form of skin cancer were given new hope today after the health watchdog recommended that two life-extending treatments should be available on the NHS.

Progression of RAS-Mutant Leukemia during RAF Inhibitor Treatment

Vemurafenib, a selective RAF inhibitor, extends survival among patients with BRAF V600E–mutant melanoma. Vemurafenib inhibits ERK signaling in BRAF V600E–mutant cells but activates ERK signaling in BRAF wild-type cells. This paradoxical activation of ERK signaling is the mechanistic basis for the development of RAS-mutant squamous-cell skin cancers in patients treated with RAF inhibitors. This study reports the accelerated growth of a previously unsuspected RAS-mutant leukemia in a patient with melanoma who was receiving vemurafenib. Exposure to vemurafenib induced hyperactivation of ERK signaling and proliferation of the leukemic cell population, an effect that was reversed on drug withdrawal.

New melanoma trial initiated at Moffitt Cancer Center to investigate utility of immunotherapy biomarkers

Phase I melanoma patient trial will test whether the drug PV-10 works better in patients with a distinct immune biomarker signature in both blood and tumor tissue.

Circulating tumor cells may be predictive for recurrence and survival in melanoma patients

Circulating tumor cells detected in the blood of stage III melanoma patients may be a predictive blood biomarker helpful for deciding which patients could benefit from aggressive adjuvant therapy.

‘‘Intermittent dosing’ strategy for BRAF inhibitor treatment holds promise for advanced melanoma

In an industry-academia collaboration, researchers have found an intermittent dose of vemurafenib, an oral BRAF inhibitor used to treat metastatic melanoma can help delay resistance in a mouse model. The results have implications for patients taking the drug.

Mutation Linked to Better Outcomes For Uveal Melanoma Patients

Researchers at Washington University found mutations in the gene SF3B1 are associated with a type of uveal melanoma that has better outcomes and is less likely to spread to other parts of the body.

Smartphone Applications for Melanoma Diagnosis Are Not All Ready for Primetime

Researchers assessed latest apps that claim to help diagnose questionable moles as melanoma. The performance of the apps is highlight variable- 3 of 4 apps incorrectly classified one-third of melanomas as “not concerning”.

New Driver Mutations of Malignant Melanoma Discovered

Researchers at the Dana-Farber and Broad Institute in Boston identified 2 mutations that collectively occur in 71 percent of malignant melanoma tumors making them more common than the BRAF mutation. These highly “recurrent” mutations may be the most common mutations in melanoma cells found to date. The mutations are located in non-protein-coding DNA that regulates the activity of genes, both located in the promoter region of TERT, the telomerase enzyme