TargetedOnc Staff Writer
Articles
FDA Considers New Warning and Label Recommendations for Breast Implants
October 28th 2019According to a statement from the FDA, the agency has issued a draft guidance proposing labeling recommendations for breast implant manufacturers that would help patients understand the benefits and risks of implants. The labeling recommendations would include the addition of a boxed warning.
Expert Considers First- and Second-Line Liver Cancer Treatment Options in 2 HCC Case Studies
July 5th 2019Aiwu Ruth He, MD, PhD, discusses treatment options in a <em>Targeted Oncology </em>live case-based peer perspectives discussion based on 2 case studies of patients with hepatocellular carcinoma.
NDA Review Period Extended by FDA for Quizartinib in FLT3-ITD+ AML
April 5th 2019The review period on the new drug application for quizartinib as a treatment for adult patients with relapsed/refractory <em>FLT3</em>-ITD–positive acute myeloid leukemia has been extended by the FDA by 3 months. This provides the FDA with additional time to review more data supplied by Daiichi Sankyo, the manufacturer of the FLT3 inhibitor.
Atezolizumab/Nab-Paclitaxel Approved by the FDA for PD-L1+ TNBC
March 8th 2019An accelerated approval has been granted by the FDA for the combination of atezolizumab and nab-paclitaxel as a frontline treatment for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer.
