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 Daratumumab Combos Breakthrough Designation for Myeloma
July 26th 2016The FDA granted daratumumab (Darzalex) a breakthrough therapy designation for use in combination with lenalidomide/dexamethasone or bortezomib/dexamethasone as a treatment for patients with multiple myeloma following at least 1 prior therapy.
Optimal Radium-223 Use Explored as Evolution of mCRPC Care Continues
July 26th 2016Daniel P. Petrylak, MD, professor of Medicine, Yale Cancer Center, discusses his vision for radium-223 dichloride (Xofigo) in patients with metastatic castration-resistant prostate cancer and how it integrates with chemotherapy and other agents for treatment of this patient population.
Novel Combination Study Planned for SCLC
July 25th 2016A phase I/II study will explore the delta-like protein 3-targeted antibody-drug conjugate rovalpituzumab tesirine (Rova-T) with the PD-1 inhibitor nivolumab (Opdivo) alone or in combination with the CTLA-4 inhibitor ipilimumab (Yervoy) for patients with relapsed extensive-stage small cell lung cancer.
CHMP Adopts Positive Opinion for Liposomal Irinotecan in Pancreatic Cancer
July 25th 2016The Committee for Medicinal Products for Human Use has recommended the approval of pegylated liposomal irinotecan (Onivyde) in combination with fluorouracil and leucovorin for patients with metastatic pancreatic adenocarcinoma following progression on a gemcitabine-based therapy.
Dreicer Addresses Key Questions With Radium-223 in mCRPC
July 25th 2016Robert Dreicer, MD, discusses the key questions that surround the optimal use and sequencing of radium-223 dichloride (Xofigo) in patients with metastatic castration-resistant prostate cancer and how the treatment has altered the field of radiopharmaceuticals.
Crizotinib Receives Positive CHMP Opinion for ROS1-Positive NSCLC
July 25th 2016The Committee for Medicinal Products for Human Use has adopted a positive option for crizotinib (Xalkori) as a treatment for adults with ROS1-positive advanced non–small cell lung cancer, suggesting an approval may be imminent.
CHMP Grants Positive Opinion for Cabozantinib in Renal Cell Carcinoma
July 22nd 2016Cabozantinib (Cabometyx) has received a positive recommendation from the EMA's Committee for Medicinal Products for Human Use for use as treatment for patients with advanced renal cell carcinoma after the failure of VEGF-targeted therapy.
Neratinib Benefit in Breast Cancer Sustained in 5-Year ExteNET Analysis
July 22nd 2016A 5-year assessment showed that neratinib reduced the risk of invasive disease recurrence or death by 26% compared with placebo as extended adjuvant therapy for patients with HER2-positive early stage breast cancer following 12 months of trastuzumab.
Pennell Provides Perspective on EGFR-Targeted Agents in NSCLC
July 21st 2016Nathan Pennell, MD, PhD, discusses 3 available—and competing—agents in EGFR-mutant non–small cell lung cancer, as well as ongoing clinical trials at Cleveland Clinic exploring other regimens for this patient population.
Expert Stresses Importance of PSA-Based Screening in Early-Stage Prostate Cancer
July 21st 2016Scott Eggener, MD, discusses the implications of the Prostate, Lung, Colorectal, and Ovary trial update, and shares his views on PSA-based screening and how to appropriately use it for patients with early-stage prostate cancer.
Steroid Mouthwash May Prevent Stomatitis in Some Breast Cancer Patients
July 21st 2016A study of women treated with the mTOR inhibitor everolimus (Afinitor) plus exemestane for their advanced breast cancer found that daily use of a steroid-based mouthwash markedly decreased the incidence and severity of stomatitis.
Role of Targeted Therapies Evolving in CLL
July 20th 2016The treatment landscape for patients with chronic lymphocytic leukemia continues to evolve, as long-term data become available from pivotal studies that led to the FDA approvals for the BTK inhibitor ibrutinib (Imbruvica) and the PI3K inhibitor idelalisib (Zydelig).
Osimertinib Extends PFS in Phase III Study for T790M-Mutant NSCLC
July 18th 2016The phase III AURA3 study has confirmed the benefits of osimertinib seen in earlier phase II studies for patients with EGFR T790M-mutant locally-advanced or metastatic non–small cell lung cancer following progression on a frontline EGFR TKI.
Obinutuzumab Falls Short in Phase III DLBCL Trial
July 18th 2016Adding the anti-CD20 agent obinutuzumab (Gazyva) to CHOP chemotherapy in the frontline setting did not improve progression-free survival compared with the standard regimen of rituximab (Rituxan) plus CHOP in patients with diffuse large B-cell lymphoma.