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.
CYP2D6 Genotype Linked With Suboptimal Outcomes in Breast Cancer
March 4th 2020Patients with breast cancer who are ultrarapid or poor CYP2D6 metabolizers of tamoxifen have a worse prognosis compared with normal metabolizers after receiving a standard dose of the drug, due, in part, to a higher incidence of treatment-related adverse events.
John Theurer Cancer Center Evaluating Personalized Cancer Vaccine in High-Risk Melanoma
March 4th 2020An ongoing clinical trial will assess whether the adjuvant combination of the personalized cancer vaccine mRNA-4157 and pembrolizumab improves recurrence-free survival compared with pembrolizumab alone in patients with complete resection of cutaneous melanoma and a high-risk of recurrence.
PROs Further Support Hypofractionated RT in Nonmetastatic Prostate Cancer
March 3rd 2020The use of moderately hypofractionated radiation therapy demonstrated no statistically significant differences in functional outcomes compared with conventionally fractionated radiation therapy, further cementing hypofractionated radiation therapy as a standard approach for patients with nonmetastatic prostate cancer.
NEJM Data Highlight Neoadjuvant Pembrolizumab Benefit in TNBC
March 3rd 2020The neoadjuvant combination of pembrolizumab plus chemotherapy led to a higher pathological complete response rate compared with placebo/chemotherapy in patients with early triple-negative breast cancer, across various patient subgroups.
FDA Grants Fast Track Designation to Tipifarnib for T-Cell Lymphomas
March 3rd 2020The FDA has granted a Fast Track Designation to tipifarnib for the treatment of adult patients with relapsed/refractory angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma, and nodal peripheral T-cell lymphoma with T follicular help phenotype.
FDA Approves Isatuximab for Relapsed/Refractory Myeloma
March 3rd 2020The FDA has approved isatuximab-irfc (Sarclisa) for use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor.
International Association for the Study of Lung Cancer Names Research Award after Dr. Fred R. Hirsch
March 2nd 2020The International Association for the Study of Lung Cancer (IASLC) announced it is naming the Translational Research Lectureship Award after longtime member and former IASLC CEO, Fred R. Hirsch, MD, PhD, Executive Director of the Center for Thoracic Oncology and Associate Director of Biomarker Discovery at The Tisch Cancer Institute at Mount Sinai and the Joe Lowe and Louis Price Professor of Medicine (Hematology and Medical Oncology) at the Icahn School of Medicine at Mount Sinai.
Brigatinib Nears EU Approval for Frontline ALK+ NSCLC
March 2nd 2020The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for brigatinib for the first-line treatment of patients with ALK-positive metastatic non–small cell lung cancer
Selinexor Regimen Improves PFS in Relapsed/Refractory Myeloma
March 2nd 2020Selinexor in combination with bortezomib and low-dose dexamethasone led to a statistically significant increase in progression-free survival compared with bortezomib/dexamethasone alone in patients with multiple myeloma who have received 1 to 3 prior lines of therapy.
FDA Grants Priority Review to Tafasitamab/Lenalidomide Combo for Relapsed/Refractory DLBCL
March 2nd 2020The FDA has granted a priority review designation to a biologics license application for the combination of tafasitamab and lenalidomide for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma.
Venetoclax Combo Misses OS Endpoint in Phase III Frontline AML Trial
March 2nd 2020Combining venetoclax with low-dose cytarabine (LDAC) did not lead to a statistically significant improvement in overall survival compared with LDAC alone in newly-diagnosed patients with acute myeloid leukemia who are ineligible for intensive chemotherapy, according to findings from the phase III VIALE-C (M16-043) trial.
Pembrolizumab Improves PFS in Relapsed/Refractory Hodgkin Lymphoma
March 2nd 2020Pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with brentuximab vedotin in adult patients with relapsed/refractory classic Hodgkin lymphoma, meeting one of the dual primary endpoints of the phase III KEYNOTE-204 trial.
NICE Recommends Lenalidomide/Rituximab for Follicular Lymphoma
February 28th 2020The United Kingdom’s National Institute for Health and Care Excellence has recommended the combination of lenalidomide and rituximab as a treatment option for adult patients with grade 1 to 3A previously treated follicular lymphoma.
FDA Takes Action on Safety Measures With Laparoscopic Power Morcellators for Gynecologic Surgery
February 28th 2020In an effort to make the use of laparoscopic power morcellators a safer and more effective choice in gynecologic surgeries, the FDA has released a statement that it will be putting a handful of strategies and recommendations in place.