On November 26, the FDA granted accelerated approval to larotrectinib (Vitrakvi, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.
Read the full FDA press release here.
Posted 11/27/2018
Decentralized clinical trial approaches, including remote consent, telehealth, local laboratory and imaging services, and more, can help reduce some of the many barriers that prevent eligible patients from participating in trials. But as the participants in ACCC’s Advancing Decentralized Clinical Trials in the Community Setting Roundtable Series emphasized, implementing DCT elements is not simply a matter of adopting new technology. Doing so successfully requires thoughtful workflows and oversight structures that consider equity, scalability, and sustainability.
