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.
Treatment-Related AEs Can Require Careful Management in Patients With RCC
January 3rd 2019Heather Greene, NP, discusses the importance of open communication between patients and providers from the onset of therapy and provided insight on the management of treatment-related adverse events in metastatic renal cell carcinoma.
Trastuzumab ADCC May Affect Outcomes in HER2+ Breast Cancer
December 28th 2018Patients with HER2-positive early or locally advanced breast cancer who were exposed to reference trastuzumab lots with a marked downward shift in antibody-dependent cell-mediated cytotoxicity (ADCC) had worse outcomes than those not exposed to at least 1 shifted ADCC lot or those treated with its biosimilar.
IMvoke010 Trial to Assess Adjuvant Atezolizumab in SCCHN
December 22nd 2018An ongoing randomized phase III study will compare the safety and efficacy of atezolizumab with placebo as adjuvant therapy after definitive local therapy in patients with high-risk, locally advanced squamous cell carcinoma of the head and neck.
FDA Delays Decision on Frontline Pembrolizumab sBLA in NSCLC
December 21st 2018The FDA has extended the review period for a supplemental biologics license application for single-agent pembrolizumab for the frontline treatment of patients with locally advanced or metastatic nonsquamous or squamous non–small cell lung cancer with a PD-L1 expression level of ≥1% and no EGFR or ALK genomic tumor aberrations.
FDA Approves Longer-Acting Calaspargase Pegol-mknl for ALL
December 21st 2018The FDA has approved a longer-acting version of calaspargase pegol-mknl (Asparlas) as a component of a multiagent chemotherapy regimen for pediatric and young adult patients aged 1 month to 21 years with acute lymphoblastic leukemia.
Olaparib Succeeds in Confirmatory Trial for Relapsed BRCA+ Ovarian Cancer
December 20th 2018The PARP inhibitor olaparib demonstrated a statistically significant and clinically meaningful improvement in objective response rate in patients with BRCA-mutant ovarian cancer who have relapsed on at least 2 prior lines of therapy.