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.
Siteman Cancer Center Awarded $7.8 Million to Expand Clinical Trials Access
August 2nd 2019Physicians at Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis have been awarded a $7.8 million grant from the National Cancer Institute to play a leading role in designing, conducting and enrolling patients in clinical trials through the NCI
FDA Grants Bempegaldesleukin Plus Nivolumab Breakthrough Designation in Melanoma
August 1st 2019The FDA granted a breakthrough therapy designation to the combination of bempegaldesleukin (NKTR-214) and nivolumab (Opdivo) for the treatment of patients with previously untreated unresectable or metastatic melanoma.
Ribociclib Improves Survival in Postmenopausal Women With Advanced Breast Cancer
July 31st 2019Adding the CDK4/6 inhibitor ribociclib to fulvestrant significantly improved overall survival as a first- or second-line treatment for postmenopausal women with hormone receptor–positive/HER2-negative breast cancer, according to findings from a preplanned interim analysis of the phase III MONALEESA-3 trial.
FDA Approves Pembrolizumab for PD-L1+ Esophageal Cancer
July 31st 2019The FDA has approved pembrolizumab for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (combined positive score ≥10) as determined by an FDA-approved test, with disease progression after ≥1 prior lines of systemic therapy.
Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel Nears EU Approval in Nonsquamous NSCLC
July 29th 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to the triplet regimen of atezolizumab (Tecentriq), carboplatin, and nab-paclitaxel (Abraxane) for the first-line treatment of patients with advanced, nonsquamous non–small cell lung cancer who do not have EGFR or ALK molecular aberrations.
EU Panel Backs Pembrolizumab Plus Axitinib for Frontline RCC
July 29th 2019The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of pembrolizumab (Keytruda) in combination with axitinib (Inlyta) for the frontline treatment of patients with advanced renal cell carcinoma.
Atezolizumab Plus Chemo Poised for EU Approval in Small Cell Lung Cancer
July 29th 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of atezolizumab in combination with carboplatin and etoposide for the frontline treatment of patients with extensive-stage small cell lung cancer.
Pembrolizumab Combo Improves pCR in Locally Advanced TNBC
July 29th 2019Pembrolizumab in combination with chemotherapy led to a statistically significant improvement in pathological complete response rates compared with placebo plus chemotherapy in the neoadjuvant phase of a neoadjuvant/adjuvant treatment regimen in patients with triple-negative breast cancer, meeting one of the dual primary endpoints of the phase III KEYNOTE-522 trial.
Elotuzumab Triplet Approaches EU Approval for Multiple Myeloma
July 29th 2019The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approving elotuzumab (Empliciti) for use in combination with pomalidomide (Pomalyst) and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor.
Larotrectinib Likely to Get EU Nod for NTRK+ Tumors
July 26th 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of larotrectinib for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
TAS-102 Nears EU Approval for Gastric Cancer
July 26th 2019The European Medicines Agency's Committee for Medicinal Products for Human Use has backed approval of TAS-102 for the treatment of adult patients with metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction, following treatment with at least 2 prior systemic regimens for advanced disease.