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 Extends Review Period for Quizartinib in AML
April 4th 2019The FDA has added 3 months to the review period for a new drug application for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia, allowing the agency to review additional data provided by Daiichi Sankyo.
Immunotherapy Shakes Up Gastric/GEJ Cancer Space, Alongside Angiogenic, Cytotoxic Agents
April 4th 2019J. Stuart Salmon, MD, highlights first-, second-, and third-line treatment options for patients with gastric and gastroesophageal cancer following recent clinical trial findings and regulatory approvals.
Cyclophosphamide-Driven Efficacy in GVHD Unaffected by Matched Unrelated Donor Status
April 3rd 2019Cyclophosphamide administered alone or in combination with other agents is an effective prophylactic treatment for graft-versus-host disease, regardless of stem cell source, conditioning intensity, or patient age in 10/10 and 9/10 human leukocyte antigen matched unrelated donor hematopoietic stem cell transplantation recipients.
Risk Factor Profile Determined for Development of Pediatric TA-TMA After HSCT
April 3rd 2019The development of high-grade acute graft-versus-host disease following hematopoietic stem cell transplantation poses the highest risk for transplant-associated thrombotic microangiopathy in pediatric patients.
Ruxolitinib/Etanercept Combo Resolves Steroid-Refractory Acute GVHD Following Allogeneic SCT
April 1st 2019A novel treatment of ruxolitinib combined with etanercept led to encouraging response and survival rates in patients who developed grades 3/4 steroid-resistant acute graph-versus-host disease after undergoing allogeneic stem cell transplantation.
[Fam]-Trastuzumab Deruxtecan Accelerates Through HER2+ Breast Cancer Pipeline
March 29th 2019An accelerated filing of a biologics license application is planned for [fam-] trastuzumab deruxtecan (DS-8201) as a treatment for patients with HER2-positive metastatic breast cancer previously treated with ado-trastuzumab emtansine.
Fulvestrant/Anastrozole Combo Improves Survival in Metastatic HR+ Breast Cancer
March 29th 2019The frontline combination of fulvestrant and anastrozole resulted in a sustained benefit in progression-free survival and a significant improvement in overall survival compared with anastrozole alone in patients with postmenopausal, HR–positive metastatic breast cancer, according to long-term results of the SWOG S0226 trial.
Enfortumab Vedotin Active After Chemo and Immunotherapy in Urothelial Carcinoma
March 28th 2019Enfortumab vedotin showed strong clinical activity in patients with locally advanced or metastatic urothelial carcinoma who previously received both platinum-containing chemotherapy and immune checkpoint therapy, according to topline results from the pivotal phase II EV-201 trial.
EU Application Filed for Daratumumab in Newly Diagnosed, Transplant-Eligible Myeloma
March 27th 2019A Type II variation application has been submitted to the European Medicines Agency for the 4-drug regimen of daratumumab, bortezomib, thalidomide, and dexamethasone as a treatment for patients with newly diagnosed multiple myeloma who are eligible to undergo autologous stem cell transplant.
Treosulfan Conditioning Regimen for Allogeneic HSCT Improves Survival for MAC-Ineligible AML, MDS
March 27th 2019Treosulfan added to fludarabine demonstrated an improvement in event-free and overall survival compared with busulfan/fludarabine as a treatment for patients with acute myeloid leukaemia or myelodysplastic syndrome who are scheduled for allogeneic hematopoietic stem cell transplantation but are considered ineligible for standard myeloablative conditioning.
FDA Grants Breakthrough Designation to Ivosidenib Combo for Newly Diagnosed IDH1+ AML
March 27th 2019The FDA has granted a breakthrough therapy designation to the combination of ivosidenib and azacitidine for the treatment of newly diagnosed patients with IDH1-mutant acute myeloid leukemia ≥75 years old or are ineligible for intensive induction chemotherapy.
FDA Approval Sought for Frontline Daratumumab Regimen in Transplant-Eligible Myeloma
March 26th 2019A supplemental biologics license application has been submitted to the FDA for daratumumab in combination with bortezomib, thalidomide, and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.