The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending Vizimpro (dacomitinib) 45 mg, as monotherapy, be granted marketing authorization in the European Union for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor-activating mutations. The CHMP's opinion will now be reviewed by the European Commission
Genentech has submitted a supplemental Biologics License Application to the FDA for Kadcyla (ado-trastuzumab emtansine) for adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment.
Merck KGaA and GSK have agreed to jointly develop and commercialize M7824 (bintrafusp alfa). M7824 is an investigational bifunctional fusion protein immunotherapy that is currently in clinical development, including potential registration studies, for multiple difficult-to-treat cancers.
FDA has initiated enforcement action against several retail locations of Walgreen Co. and Circle K Stores Inc. for repeated violations of restrictions on the sale and distribution of tobacco products, including sales of cigars and menthol cigarettes to minors.
Researchers at Georgetown Lombardi Comprehensive Cancer Center released a study that may show immunotherapy offers similar benefit to cancer patients living with HIV.
The first report from a phase II, multi-center clinical trial indicates that a newer, more aggressive form of radiation therapy, stereotactic radiation, can extend long-term survival for some patients with stage-IV cancers while maintaining their quality of life.
Noxopharm announced interim results from the dose-ranging component of the DARRT-1 study. Some of their key findings include combining Veyonda with low-dose radiotherapy applied to a single metastasis is able to produce an anti-cancer response in both the irradiated and non-irradiated lesions as evidenced by PSA response, pain reduction, and/or tumour measurements.
A study in JNCI Cancer Spectrum has identified a connection between prolonged time spent sitting while watching TV and an increased risk of colorectal cancer for younger Americans.
Foundation Medicine Inc. announced a nationwide contract with the U.S. Department of Veterans Affairs National Precision Oncology Program to provide comprehensive genomic profiling for eligible Veterans with advanced cancer.
Brian HigginsPeter KingBrian FitzpatrickLeading the House of Representatives Cancer Caucus are co-chairs House members Brian Higgins (D-NY), Peter King (R-NY), Derek Kilmer (D-WA), and Brian Fitzpatrick (R-PA).
