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 Rucaparib Breakthrough Designation for mCRPC
October 2nd 2018The FDA has granted the PARP inhibitor rucaparib a breakthrough therapy designation for single-agent use in adult patients with BRCA1/2-positive metastatic castration-resistant prostate cancer following at least 1 androgen receptor–directed therapy and taxane-based chemotherapy.
Brentuximab Vedotin Improves Survival in Frontline CD30+ PTCL
October 2nd 2018Combining brentuximab vedotin with frontline chemotherapy led to a statistically significant improvement in progression-free and overall survival in patients with CD30-expressing peripheral T-cell lymphoma, according to topline results from the phase III ECHELON-2 trial.
Allison, Honjo Win Nobel Prize for Research on Immune Checkpoints
October 1st 2018Immunotherapy pioneers James P. Allison, PhD, and Tasuku Honjo, MD, PhD, have won the 2018 Nobel Prize in Physiology or Medicine for their research that eventually led to the use of immune checkpoint inhibitors to treat cancer.
FDA Approves Cemiplimab for CSCC
September 29th 2018The FDA has approved the PD-1 inhibitor cemiplimab (Libtayo) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation.
Regimen Could Reduce Cardiotoxicity in HER2+ Breast Cancer
September 28th 2018Women with operable HER2-positive breast cancer had similar long-term survival outcomes with either concurrent or sequential chemotherapy in the neoadjuvant setting, according to newly published results from the phase III ACOSOG Z1041 trial.