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 Approves Frontline Venetoclax in AML
November 21st 2018The FDA has granted an accelerated approval to venetoclax for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of adult patients with newly-diagnosed acute myeloid leukemia (AML) who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
Avelumab Misses Primary Endpoints in Phase III Ovarian Cancer Trial
November 19th 2018Avelumab (Bavencio) alone or in combination with pegylated liposomal doxorubicin did not induce a statistically significant improvement in overall survival or progression-free survival versus pegylated liposomal doxorubicin alone in patients with platinum-resistant/-refractory ovarian cancer.
EU Panel Backs Apalutamide in Nonmetastatic CRPC
November 19th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use granted support for approval of apalutamide for the treatment of adult patients with nonmetastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease.
Thoracic Oncologist Highlights Recent Pembrolizumab Data in NSCLC
November 19th 2018Pembrolizumab (Keytruda) has emerged as an effective frontline treatment option for select patients with metastatic non–small cell lung cancer, showing an overall survival advantage across 3 phase III clinical trials.
Novel Agent Active Across Heavily Pretreated HER2+ Tumors
November 17th 2018The novel bispecific antibody ZW25 induced a disease control rate of 82% in heavily pretreated patients across several HER2-positive tumor types, according to phase I study results presented at the 2018 EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium.
Nivolumab/Ipilimumab Combo Nears EU Approval for Frontline RCC
November 17th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of nivolumab combined with low-dose ipilimumab as a frontline treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma.
Novel Drug Combination Shows Early Activity in Microsatellite Stable CRC
November 17th 2018Pixatimod (PG545) in combination with the PD-1 inhibitor nivolumab (Opdivo) may benefit patients with advanced bowel cancers, including a small subset of those with colorectal cancer considered to be microsatellite stable.
Blinatumomab Approaches European Approval for MRD+ ALL
November 17th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of blinatumomab for the treatment of adult patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease of at least 0.1%.
EU Panel Backs Expanding Ribociclib Approval in HR+/HER2- Breast Cancer
November 17th 2018The European Medicine’s Agency Committee for Medicinal Products for Human Use has recommended expanding the approval of ribociclib (Kisqali) in women with HR+/HER2-negative breast cancer to include use in combination with fulvestrant (Faslodex).
Durvalumab Combo Misses OS Endpoint in Frontline Metastatic NSCLC
November 16th 2018The frontline combination of durvalumab (Imfinzi) and tremelimumab did not induce a statistically significant improvement in overall survival compared to standard chemotherapy in patients with metastatic non–small cell lung cancer.