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.
Health Policy Director Discusses ACCC's Take on ACA Repeal, MedPAC's Part B Recommendations
April 28th 2017Leah Ralph discusses the ACCC’s position on the Afforadable Care Act repeal bill, the Medicare Payment Advisory Commission’s Part B cost control proposals, and the possibility for comprehensive reform on the 340B Drug Discount Program.
COA Highlights Concern Over Growing Influence of PBMs
April 28th 2017Josh Cox, PharmD, moderated a panel discussion on legislative initiatives to combat the rising power of Pharmacy Benefit Managers at the 2017 Community Oncology Conference. In the talk, he touched on the difficulties of monitoring therapy for patients receiving their drugs from outside pharmacies as well as murkiness off drug pricing and cash flow within the PBM systems.
FDA Approves Midostaurin for AML
April 28th 2017The FDA has approved midostaurin (Rydapt) for the treatment of adult patients with newly diagnosed FLT3-positive acute myeloid leukemia in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. The drug has also been approved for the treatment of patients with advanced systemic mastocytosis (SM), including aggressive systemic mastocytosis, SM with associated hematological neoplasm, and mast cell leukemia.
FDA Grants Lorlatinib Breakthrough Designation for NSCLC
April 27th 2017The FDA has granted a breakthrough therapy designation to lorlatinib for use in patients with ALK-positive metastatic NSCLC who have previously received 1 or more ALK inhibitors, according to Pfizer, the company developing the next-generation ALK/ROS1 TKI.
EU Grants Full Approval to Osimertinib for EGFR T790M-Positive NSCLC
April 27th 2017The European Union has granted a full approval to osimertinib (Tagrisso) for the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive non–small cell lung cancer, regardless of prior treatment with an EGFR TKI.
Expert Highlights Novel Combos, Potential of Immunotherapy in MCL
April 25th 2017Stephen M. Ansell, MD, PhD, discusses emerging combinations being investigated in patients with mantle cell lymphoma, the possible role of immunotherapy, and challenges oncologists are still struggling with in this population.
Abemaciclib Improves PFS in Phase III MONARCH 3 Breast Cancer Trial
April 24th 2017Adding abemaciclib to letrozole or anastrozole improved progression-free survival compared with either aromatase inhibitor alone in women with HR+/HER2-negative breast cancer enrolled in the phase III MONARCH 3 study, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.
Complete Response to Chemo Critical in CLL Patients Who Develop Hodgkin Lymphoma
April 24th 2017Achieving a complete response following ABVD chemotherapy offered the best chance for survival for patients with chronic lymphocytic leukemia who developed Hodgkin lymphoma following Richter transformation, according to a retrospective study published in the American Journal of Hematology.
Ibrutinib Better Than Bendamustine for OS in CLL, Indirect Comparison Suggests
April 21st 2017Results of a systematic literature search published online in Clinical Lymphoma, Myeloma & Leukemia showed that ibrutinib was associated with superior survival and fewer adverse events compared with bendamustine in patients with chronic lymphocytic leukemia.
Findings Support Early Use of CD19 CAR T-Cell Therapy in Relapsed B-cell ALL
April 21st 2017Low disease burden prior to treatment with CD19-specific chimeric antigen receptor T-cell therapy appears to be a positive prognostic factor for long-term survival outcomes of patients with relapsed B-cell acute lymphoblastic leukemia.