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.
Quizartinib Receives Japanese Approval in Relapsed/Refractory FLT3+ AML
June 18th 2019The Ministry of Health, Labor and Welfare of Japan has approved quizartinib for the treatment of adult patients with relapsed/refractory FTL3-ITD–positive acute myeloid leukemia, as detected by an MHLW-approved assay.
Entrectinib Breaks Through With Japanese Approval for NTRK-Positive Tumors
June 18th 2019Entrectinib received its first regulatory approval, as Japan’s Ministry of Health, Labour and Welfare has approved the drug for the treatment of adult and pediatric patients with NTRK fusion–positive, advanced recurrent solid tumors.
Frontline Maintenance Olaparib Approved in Europe for Ovarian Cancer
June 18th 2019The European Commission has approved olaparib as a single agent for the maintenance treatment of adult patients with advanced BRCA1/2-mutated germline and/or somatic high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response following first-line platinum-based chemotherapy.
FDA Approves Pembrolizumab for Metastatic SCLC
June 18th 2019The FDA has granted an accelerated approval to single-agent pembrolizumab for the treatment of patients with metastatic small cell lung cancer who have disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy.
Single-Agent Acalabrutinib Showcases Potential Practice-Changing Data in Relapsed/Refractory CLL
June 17th 2019Chemotherapy-free treatment with single-agent acalabrutinib provided a statistically significant and clinically meaningful improvement in progression-free survival compared with physicians’ choice of standard therapy in patients with previously treated chronic lymphocytic leukemia.
Immunotherapy Revolutionizes Squamous NSCLC, But Biomarker Enhancement Needed
June 17th 2019Chad Pecot, MD, discusses practice-changing immunotherapy research that has read out in squamous non–small cell lung cancer, emerging biomarkers under investigation, and logical combinations that beg for further exploration.
FDA Approves Fifth Trastuzumab Biosimilar
June 14th 2019The FDA has approved ABP 980 (Kanjinti; trastuzumab-anns), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, marking the fifth approval by the agency for a trastuzumab biosimilar.
Avelumab/Axitinib Combo Biomarker Analysis May Lend Insight to Complex RCC Landscape
June 11th 2019Toni Choueiri, MD, discusses the biomarker analysis results from JAVELIN Renal 101 and provided insight on where the renal cell carcinoma field stands following pivotal data presented at the 2019 ASCO Annual Meeting.
FDA Approves Single-Agent Pembrolizumab or Plus Chemo for Frontline HNSCC
June 11th 2019The FDA has approved pembrolizumab (Keytruda) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma as monotherapy whose tumors express PD-L1 (composite positive score [CPS] ≥1) and also in combination with platinum and fluorouracil (FU) for this patient population, irrespective of PD-L1 expression.
Novel Cedazuridine/Decitabine Combo Meets Primary Endpoint in Phase III MDS/CMML Trial
June 8th 2019The fixed-dose combination of cedazuridine and decitabine demonstrated decitabine exposure equivalence of total 5-day dosing compared with intravenous decitabine in patients with intermediate- and high-risk myelodysplastic syndromes or chronic myelomonocytic leukemia, meeting the primary endpoint of the phase III ASCERTAIN trial.
Brigatinib Elicits Responses in ALK+ NSCLC Following Next-Generation TKIs
June 7th 2019Brigatinib demonstrated promising response rates in patients with ALK-positive non–small cell lung cancer who have progressed on treatment with another next-generation ALK TKI, according to preliminary phase II results presented at the 2019 ASCO Annual Meeting.
SOLO-1 Olaparib Trial Fosters Novel Applications of Frontline Maintenance in Ovarian Cancer
June 7th 2019Mihaela C. Cristea, MD, discusses the impact of the SOLO-1 trial on current approaches to frontline maintenance therapy as well as the trials that are underway with niraparib, rucaparib, and the investigational PARP inhibitor veliparib.
Acalabrutinib/Obinutuzumab Combo Improves PFS in Frontline CLL
June 6th 2019The combination of acalabrutinib (Calquence) and obinutuzumab (Gazyva) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with obinutuzumab/chlorambucil in patients with previously untreated chronic lymphocytic leukemia, meeting the primary endpoint of the phase III ELEVATE-TN trial.