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 Priority Review to Afatinib for NSCLC With Rare EGFR Mutations
October 11th 2017The FDA has granted a priority review to a supplemental new drug application for afatinib for the frontline treatment of patients with metastatic non-small cell lung cancer whose tumors harbor EGFR exon 21 (L861Q), G719X, or S768I substitution mutations.
FDA Approval Sought for Maintenance Rucaparib in Ovarian Cancer
October 10th 2017A supplemental new drug application has been submitted to the FDA for rucaparib as maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
No Survival Benefit With Abemaciclib in KRAS+ NSCLC
October 10th 2017In topline results from the phase III JUNIPER trial, abemaciclib failed to meet its primary endpoint of improving overall survival versus erlotinib in patients with KRAS-mutated, advanced non–small cell lung cancer (NSCLC) who progressed after platinum-based chemotherapy.
Southern Cancer Center is Global Leader in Kidney Cancer Clinical Trial
October 9th 2017Southern Cancer Center, a premier oncology clinic in Alabama and a practice in The US Oncology Network, is the first site in the world to open enrollment for a new clinical trial for newly diagnosed kidney cancer patients.
Reinduction Regimen Effective in Late Marrow-Relapsed Pediatric ALL
October 6th 2017In the CALL-0603 study of 44 patients with first marrow-relapsed childhood acute lymphoblastic leukemia, the second complete remission rate was 72.7% for a chemotherapy regimen that included a reduced dose of idarubicin.
Advancing Stage III NSCLC Care Requires Personalized, Multidisciplinary Approach
October 5th 2017Thomas A. Hensing, MD, discussed that modern technology and novel therapeutics must be managed by a multidisciplinary team to achieve optimal outcome for patients with stage III non-small cell lung cancer.
FDA Grants Pertuzumab Priority Review for HER2+ Early Breast Cancer
September 29th 2017The FDA has granted a priority review to a supplemental biologics license application for pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer.
FDA Approves Abemaciclib for HR+/HER2- Breast Cancer
September 28th 2017The FDA approved abemaciclib (Verzenio) for use in combination with fulvestrant in women with HR+/HER2- advanced breast cancer with disease progression following endocrine therapy. The CDK4/6 inhibitor has also been approved as a monotherapy for patients with HR+/HER2- breast cancer with metastatic disease who have previously received endocrine therapy and chemotherapy.