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 Atezolizumab Priority Review in Bladder Cancer
March 15th 2016The FDA has granted a priority review to atezolizumab as a treatment for patients with locally advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.
FDA Approves New Melphalan Formulation in Myeloma
March 15th 2016The FDA has approved Captisol-enabled melphalan (Evomela) as a high-dose conditioning treatment for use in patients with multiple myeloma prior to autologous stem cell transplantation, as well as for the palliative treatment of patients with myeloma for whom oral therapy is not appropriate.
Atezolizumab Approaches FDA Approval in Bladder Cancer, But Biomarkers Remain Unclear
March 15th 2016Matthew Galsky, MD, explains the challenges of utilizing molecular subtyping and PD-L1 as biomarkers, the impact a potential approval of atezolizumab could have in metastatic bladder cancer, possible combinations that could increase ORR, and next steps in understanding the IMvigor study.
Earlier Abiraterone More Effective for Chemo-Naïve mCRPC
March 14th 2016Treatment with abiraterone acetate plus prednisone demonstrated an 11.8-month improvement in overall survival compared with prednisone and placebo for men with less advanced, chemotherapy-naïve metastatic castration-resistant prostate cancer.
Clinical Utility of Emerging Molecular Diagnostics in Breast Cancer
The past decade of biomarker research has led to the introduction of several multigene prognostic tests that are now routinely used in clinical decision making to assist the se-lection of patients for adjuvant chemotherapy, and several other tests have emerged with potential clinical utility.
Expert Shares Challenges, Considerations When Using Immunotherapies in Melanoma
March 7th 2016Michael Postow, MD, discusses the benefits and challenges of combination regimens versus single-agent regimens, the possibility of targeted agents with immunotherapies, and the management of toxicities with immunotherapies.
Personalized Therapy Emerging for Patients With Prostate Cancer
March 6th 2016Tomasz M. Beer, MD, FACP, discusses how having a deeper understanding of the genetic makeup of patients with castration-resistant prostate cancer would open the door to novel treatments, both monotherapy and combination regimens.
FDA Approval Sought for Blinatumomab in Pediatric Acute Lymphoblastic Leukemia
March 3rd 2016A supplemental biologics license application has been submitted to the FDA to expand the approval of blinatumomab (Blincyto) to include the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.