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.
NEJM Data Highlight Gilteritinib Survival Benefit in FLT3+ AML
November 1st 2019Gilteritinib demonstrated a higher remission rate and a statistically significant improvement in overall survival compared with salvage chemotherapy in patients with relapsed/refractory acute myeloid leukemia who harbor a FLT3 mutation.
Umbralisib Hits Primary Endpoint in Follicular Lymphoma Subgroup of Pivotal Study
October 29th 2019Umbralisib (TGR-1202) met the primary endpoint of overall response rate in the follicular lymphoma cohort of the pivotal phase IIb UNITY-NHL trial, according to TG Therapeutics, Inc., the developer of the PI3K-delta inhibitor.
Durvalumab Regimens Improve PFS in Frontline Metastatic NSCLC
October 29th 2019The addition of durvalumab (Imfinzi) to platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with chemotherapy alone in patients with previously untreated metastatic non–small cell lung cancer.
FDA Will Split Avapritinib GIST NDA Into Separate Submissions
October 28th 2019The FDA has informed Blueprint Medicines that it intends to split the proposed indications for its agent avapritinib into two separate new drug applications for patients with gastrointestinal stromal tumor (GIST): one for patients with PDGFRA exon 18–mutant disease regardless of prior therapy, and one for fourth-line GIST.
MCLA-128 Shows Clinical Activity in NRG1+ Solid Tumors
October 28th 2019MCLA-128, an investigational bispecific HER2/HER3 antibody, demonstrated radiological and clinical responses in patients with metastatic pancreatic ductal adenocarcinoma and metastatic non–small cell lung cancer who have NRG1 fusions.