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.
BMS Withdraws Romidepsin Relapsed/Refractory PTCL Indication in the United States
August 3rd 2021Bristol Myers Squibb has made the decision to withdraw in the indication for romidepsin as a monotherapy for the treatment of adult patients with peripheral T-cell lymphoma who have previously received at least 1 therapy.
FDA Grants Priority Review to Adjuvant Atezolizumab for PD-L1+ Early-Stage NSCLC
August 3rd 2021The FDA has granted priority review to a supplemental biologics license application for atezolizumab as an adjuvant treatment after surgery and platinum-based chemotherapy in patients with non–small cell lung cancer whose tumors have a PD-L1 expression of 1% or higher per an FDA-approved test.
CEACAM5 Joins a Growing Menu of Emerging Lung Cancer Targets
August 3rd 2021After nearly two decades of successfully developing therapies directed at molecular aberrations in non–small cell lung cancer, investigators are exploring a new generation of novel targets, including some not specifically associated with driver mutations.
Pevonedistat Shows Promising Partner Potential for HMAs in Higher-Risk MDS
August 3rd 2021Joshua F. Zeidner, MD, discusses the role that HMAs have played in the MDS treatment landscape and shared data reported with promising emerging agents like pevonedistat that can be combined with HMAs to improve outcomes for certain patient subsets.
CDK4/6 Inhibitors Improve OS, but Sequencing Strategies Continue to Form in HR+/HER2- Breast Cancer
August 2nd 2021Sara A. Hurvitz, MD, highlights that although differences in overall survival and toxicity profile could inform treatment selection with CDK4/6 inhibitors, optimal sequencing with these agents remains uncertain.
Imetelstat Elicits Efficacy Across Molecularly Defined Subgroups of Lower-Risk MDS
August 2nd 2021Treatment with imetelstat demonstrated clinical efficacy across molecularly defined subgroups of patients with heavily transfused, lower-risk myelodysplastic syndrome who did not harbor 5q deletions and were relapsed/refractory to erythropoiesis-stimulating agents.
Ivosidenib/Azacitidine Significantly Improves EFS in Previously Untreated IDH1-Mutated AML
August 2nd 2021The combination of ivosidenib plus azacitidine significantly improved event-free survival compared with azacitidine plus placebo in previously untreated patients with IDH1-mutated acute myeloid leukemia, meeting the primary end point of the phase 3 AGILE trial.
African Ancestry Is Linked With Higher Prostate Cancer Risk Vs European Ancestry
August 2nd 2021Germline variation could play a role in racial disparities related to prostate cancer risk, with individuals of African descent having a higher mean genetic risk score compared with men of European ancestry.
KRAS Inhibitors Reach New Milestones in NSCLC
July 31st 2021Significant advances have been made regarding the development of KRAS G12C inhibitors in non–small cell lung cancer in recent years, explained Karen L. Reckamp, MD, who added that research regarding predictive co-mutations, acquired resistance, and combination strategies is expected to propel the utility of these agents even further.
CDK4/6 Inhibitors Continue to Build Traction in Early-Stage ER+/HER2- Breast Cancer
July 30th 2021Neoadjuvant and adjuvant treatment with CDK4/6 inhibitors has shown encouraging preliminary evidence in patients with estrogen receptor–positive, HER2-negative breast cancer, but confirmation of durable benefit is needed in the adjuvant setting before they are brought into routine clinical practice.
FDA Grants Fast Track Status to Eryaspase for Hypersensitive Acute Lymphocytic Leukemia
July 30th 2021The FDA has granted a fast track designation to eryaspase for use as a potential therapeutic option in patients with acute lymphocytic leukemia who have developed hypersensitivity reactions to Escherichia coli–derived pegylated asparaginase.