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.
Expert Explains Clinical Developments With Cytoreductive Nephrectomy in mRCC
January 9th 2020Ulka Vaishampayan, MD, discusses the historical management of patients with metastatic renal cell carcinoma and how advances with systemic therapy have impacted the sequencing of cytoreductive nephrectomy in the treatment paradigm.
Pralsetinib Highly Active in RET+ NSCLC, Rolling FDA Submission Started
January 9th 2020The RET inhibitor pralsetinib demonstrated encouraging and durable responses in patients with RET fusion–positive non–small cell lung cancer who were both treatment-naïve and received prior treatment with platinum-based chemotherapy.
FDA Approves Pembrolizumab for High-Risk NMIBC
January 9th 2020The FDA has approved pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Pembrolizumab Combo Hits PFS, But Not OS Endpoint in Frontline Small Cell Lung Cancer
January 7th 2020The combination of pembrolizumab and chemotherapy improved progression-free survival compared with chemotherapy alone as a first-line treatment for patients with extensive-stage small cell lung cancer.
NICE Cites Cost in Deciding Against Atezolizumab for Frontline Advanced Small Cell Lung Cancer
January 7th 2020The United Kingdom’s National Institute for Health and Care Excellence did not recommend granting marketing authorization to atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the treatment of patients with treatment-naïve extensive-stage small cell lung cancer.
Itacitinib Misses Primary Endpoint in Frontline Acute GVHD
January 7th 2020The combination of itacitinib and corticosteroids did not induce a statistically significant improvement in overall response rate at day 28 compared with placebo plus corticosteroids in patients with treatment-naïve acute graft-versus-host disease, missing the primary endpoint of the phase III GRAVITAS-301 trial.
Avelumab Improves OS as Frontline Maintenance in Urothelial Carcinoma
January 6th 2020Frontline maintenance therapy with avelumab plus best supportive care demonstrated a statistically significant improvement in overall survival compared with best supportive care alone in patients with previously untreated locally advanced or metastatic urothelial carcinoma, regardless of PD-L1 expression.
Real-World Abemaciclib Use in MBC Is Heterogeneous
January 3rd 2020In the first 11 months following the FDA approval of the CDK4/6 inhibitor abemaciclib as a single agent and in combination with endocrine therapy for the treatment of hormone receptor-positive, HER2-negative metastatic breast cancer, it is being used heterogeneously, including in patients with characteristics indicative of worse prognosis.