The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
FDA Grants Priority Review to Olaparib for HRR-Mutant mCRPC
January 21st 2020The FDA has granted a priority review designation to a supplemental new drug application for olaparib (Lynparza) for the treatment of patients with metastatic castration-resistant prostate cancer who have deleterious or suspected deleterious or somatic homologous recombination repair gene mutations, and who have also progressed on prior therapy with a new hormonal agent.
NICE Cites Uncertainty in Deciding Against Larotrectinib in NTRK Fusion+ Solid Tumors
January 18th 2020The National Institute for Health and Care Excellence does not recommend larotrectinib for the treatment of advanced NTRK fusion–positive solid tumors in adults and children without satisfactory treatment options.
NICE Rejects Treatments for Head and Neck Cancer and AML
January 16th 2020The United Kingdom’s National Institute for Health and Care Excellence has issued guidelines recommending against pembrolizumab for use in treatment-naïve patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma whose tumors express PD-L1 with a combined positive score of ≥1.
NICE Recommends Olaparib Maintenance in Relapsed, Platinum-Sensitive Ovarian Cancer
January 16th 2020The National Institute for Health and Care Excellence has recommended the use of olaparib as a maintenance treatment in adults with relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
FDA Grants Priority Review to Frontline Nivolumab/Ipilimumab in Advanced NSCLC
January 15th 2020The FDA has granted a priority review designation to a supplemental biologics license application for the combination of nivolumab and ipilimumab for the first-line treatment of patients with metastatic or recurrent non–small cell lung cancer that does not have EGFR or ALK genomic tumor aberrations.
Predictive Assays Help Personalize Care in Early-Stage HR+ Breast Cancer
January 15th 2020Stephanie L. Graff, MD, discusses the importance of using genomic risk to tailor treatment to patients with early-stage hormone receptor-positive, HER2-negative disease, the benefit of extended endocrine therapy, and ongoing research with CDK4/6 inhibitors and immunotherapy.
Sintilimab Injection Plus Chemo Improves PFS in Frontline Nonsquamous NSCLC
January 14th 2020The first-line combination of sintilimab injection plus pemetrexed and platinum-based therapy showed a statistically significant improvement in progression-free survival compared with chemotherapy and placebo in patients with advanced or recurrent nonsquamous non–small cell lung cancer who did not harbor EGFR or ALK abnormalities, according to an interim analysis of the phase III ORIENT-11 trial.
John Theurer Cancer Center Investigators Report Poor Colorectal Cancer Biomarker Testing Rates
January 14th 2020Investigators at John Theurer Cancer Center at Hackensack University Medical Center in New Jersey are the first to report poor adherence to genomic profiling guidelines for four biomarkers of metastatic colorectal cancer used to predict response to therapy, choose the most effective treatment, and improve outcomes — showing that only 40% of patients had their tumors tested.
FDA Grants Priority Review to Olaparib Plus Bevacizumab as Frontline Maintenance in Ovarian Cancer
January 13th 2020The FDA has granted a priority review designation to a supplemental new drug application for the combination of olaparib and bevacizumab for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy with bevacizumab.