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.
ASCO 2017: Same-Day Dosing Cuts Costs
May 26th 2017Researchers achieved cost savings and cut down on the amount of drug they had to throw away by pooling drug vials and dosing all patients with a given disease on the same day of the week, according to data released ahead of the 2017 ASCO Annual Meeting.
FDA Grants Pembrolizumab Priority Review for Advanced Gastric Cancer
May 24th 2017The FDA has granted a priority review to a supplemental Biologics License Application for pembrolizumab (Keytruda) for the treatment of patients who have undergone at least 2 courses of chemotherapy for recurrent or advanced gastric or gastroesophageal junction adenocarcinoma.
FDA Panel Supports Neratinib Approval for HER2+ Breast Cancer
May 24th 2017The FDA’s Oncologic Drugs Advisory Committee voted 12-4 recommending approval of neratinib (Nerlynx) for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following postoperative trastuzumab.
FDA Approves Pembrolizumab for Microsatellite Instability-High and Mismatch Repair Deficient Cancers
May 23rd 2017The FDA has granted an accelerated approval to pembrolizumab (Keytruda) for the treatment of patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed after prior treatment and who have no satisfactory alternative treatment options, as well as for patients with MSI-H or dMMR colorectal cancer following progression on a fluoropyrimidine, oxaliplatin, and irinotecan.
Expert Explains Individualized Decision on Endocrine Therapy Beyond 5 Years in Breast Cancer
May 22nd 2017Amye J. Tevaarwerk, MD, discusses how physicians decide on extending endocrine therapy beyond 5 years for patients with ER-positive breast cancer, the tools she hopes will soon become available to help clarify this decision, and the clinical research in this population she is eagerly awaiting.
Future of Immunotherapy in Head and Neck Cancer May Be in Combinations
May 22nd 2017Researchers are hoping to build on the success of the KEYNOTE-012 and CheckMate-141 trials, which led to the approvals of pembrolizumab and nivolumab, respectively, by examining anti–PD-1/PD-L1 agents in the frontline and as a part of combination regimens for patients with head and neck cancer.
Bevacizumab Benefit Varies Among Ovarian Cancer Subtypes
May 19th 2017Patients with proliferative or mesenchymal ovarian tumors treated with bevacizumab (Avastin) had superior progression-free survival and a trend toward improved overall survival compared with patients with immunoreactive or differentiated tumors.
Ceritinib Recommended for EU Approval in Frontline ALK+ NSCLC
May 19th 2017The EMA’s Committee for Medicinal Products for Human Use has recommended approval of ceritinib (Zykadia) for the treatment of patients with ALK-positive, metastatic non–small cell lung cancer, according to Novartis, the manufacturer of the second-generation ALK inhibitor.