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.
EU Approves Abiraterone for Newly Diagnosed Hormone-Sensitive Prostate Cancer
November 22nd 2017The European Commission has approved abiraterone acetate (Zytiga) in combination with prednisone/prednisolone for the treatment of adult men with newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer.
FDA Approval Sought for Frontline Daratumumab in Myeloma
November 22nd 2017A supplemental biologics license application has been submitted to the FDA for daratumumab for use in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.
Atezolizumab/Bevacizumab Combo Improves PFS for Untreated Advanced NSCLC
November 20th 2017The addition of atezolizumab to bevacizumab, carboplatin, and paclitaxel delayed progression or death compared with bevacizumab and chemotherapy alone for patients with advanced non-squamous non–small cell lung cancer.
FDA Grants BCMA CAR T-Cell Therapy Breakthrough Designation in Myeloma
November 17th 2017The FDA has granted the the anti–B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy bb2121 a breakthrough therapy designation for previously treated patients with relapsed/refractory multiple myeloma.
Lower-Dose Sorafenib Linked to Reduced Discontinuation Rate in HCC
November 16th 2017Results from a retrospective, multi-institutional study showed that lowering the dose of sorafenib (Nexavar) for patients with HCC reduced pill burden and treatment costs, while showing a trend toward improved treatment completion.
FDA Approves Faslodex/Abemaciclib for HR+/HER2- Breast Cancer
November 15th 2017The FDA has approved fulvestrant (Faslodex) for use in combination with the CDK4/6 inhibitor abemaciclib (Verzenio) to treat patients with HR+/HER2- advanced or metastatic breast cancer who have progressed after endocrine therapy.
Brentuximab Vedotin Nears European Approval for CTCL
November 15th 2017The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of brentuximab vedotin (Adcetris) in adults with CD30-positive cutaneous T-cell lymphoma after at least 1 prior systemic therapy.