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.
Dabrafenib and Trametinib Combination Granted Priority Review Designation by FDA
September 16th 2013The FDA has granted Priority Review designation to dabrafenib (Tafinlar) and trametinib (Mekinist) as a combination treatment for patients with unresectable or metastatic melanoma with a BRAFV600E/K mutation.
In Historic Vote, ODAC Suggests Approval of Neoadjuvant Pertuzumab Regimen
September 12th 2013The FDA's Oncologic Drugs Advisory Committee voted 13-0 with one abstention in support of pertuzumab in combination with trastuzumab and docetaxel for patients with HER2-positive breast cancer in the neoadjuvant setting.
Breakthrough Designation Granted to Entinostat for Advanced Breast Cancer
September 11th 2013The novel HDAC inhibitor entinostat in combination with exemestane has received a Breakthrough Therapy designation from the FDA for its potential to reverse resistance to hormonal therapies used to treat patients with advanced ER-positive breast cancer.
Maintenance Olaparib Resurrected for Phase III Program
September 4th 2013The first patient has been enrolled in a phase III clinical program investigating treatment with olaparib for patients with BRCA-mutated ovarian cancer, marking another step in the revived development of an agent once relegated to the sidelines.
Ruxolitinib Plus Capecitabine Improves Survival in Pancreatic Cancer
August 21st 2013Adding ruxolitinib to capecitabine significantly improved the survival rate of a subgroup of patients with recurrent or treatment-refractory pancreatic cancer compared with patients in the same population who received capecitabine alone.
First-Line Necitumumab Improves Survival in Metastatic Squamous NSCLC
August 13th 2013A phase III trial exploring necitumumab plus chemotherapy as a first-line therapy for patients with metastatic squamous non-small cell lung cancer has demonstrated an improvement in overall survival when compared to chemotherapy alone.
Tamoxifen Significantly Lowers Risk of Contralateral Breast Cancer in BRCA-Positive Patients
August 6th 2013Patients with mutations of BRCA1 or BRCA2 who received tamoxifen after their initial diagnosis of breast cancer reduced their chances of developing contralateral or secondary breast cancer by more than half.