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 Frontline Eltrombopag Breakthrough Designation for Severe Aplastic Anemia
January 4th 2018The FDA has granted a breakthrough therapy designation to eltrombopag (Promacta) for use in combination with standard immunosuppressive therapy as a first-line treatment for patients with severe aplastic anemia.
FDA Grants Ribociclib Breakthrough Designation for HR+/HER2- Premenopausal Breast Cancer
January 3rd 2018The FDA has granted ribociclib a breakthrough therapy designation for use in combination with tamoxifen or an aromatase inhibitor as frontline treatment for pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.
FDA Grants Priority Review to Frontline Brentuximab Vedotin for Hodgkin Lymphoma
January 2nd 2018The FDA has granted a priority review to a supplemental biologics license application for brentuximab vedotin (Adcetris) in combination with Adriamycin, vinblastine, and dacarbazine (AVD) as a frontline treatment for advanced classical Hodgkin lymphoma.
Dual HER2 Blockade Superior for PFS in HER2+/HR+ Metastatic Breast Cancer
December 29th 2017The combination of lapatinib, trastuzumab, and an aromatase inhibitor (AI) reduced the risk for death or progression by 38% in women with HER2+/HR+ metastatic breast cancer compared with those treated with a targeted agent plus AI.