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.
Ublituximab Plus Ibrutinib Improves PFS in Relapsed/Refractory High-Risk CLL
October 25th 2019The combination of ublituximab and ibrutinib improved progression-free survival, as determined by an Independent Review Committee, compared with ibrutinib alone in patients with relapsed/refractory high-risk chronic lymphocytic leukemia.
European Commission Approves 4-Week Nivolumab Dosing Schedule in Adjuvant Melanoma
October 24th 2019The European Commission has approved nivolumab at a flat dosing schedule of either 240 mg over 30 minutes every 2 weeks, or 480 mg infused over 60 minutes every 4 weeks, for the adjuvant treatment of patients with melanoma who have involvement of lymph nodes or metastatic disease who have undergone complete resection.
Margetuximab Elicits Modest Survival Extension in HER2+ Breast Cancer
October 24th 2019The combination of margetuximab and chemotherapy induced a 1.8-month median overall survival increase in patients with pretreated HER2-positive metastatic breast cancer compared with trastuzumab (Herceptin) and chemotherapy.
FDA Approves Niraparib for HRD+ Advanced Ovarian Cancer
October 23rd 2019The FDA has approved niraparib (Zejula) for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 prior chemotherapy regimens, and whose cancer is associated with homologous recombination deficiency–positive status.
FDA Recommends Boxed Warning, Additional Labeling Measures for Breast Implants
October 23rd 2019The FDA has issued a draft guidance to propose labeling recommendations, including a boxed warning, to breast implant manufacturers in an effort to help patients understand the benefits and risks of these devices.
Nivolumab/Ipilimumab Plus Chemo Improves OS in Frontline NSCLC
October 22nd 2019The first-line combination of nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) given concomitantly with 2 cycles of chemotherapy showed superior overall survival compared with up to 4 cycles of chemotherapy alone followed by optional maintenance treatment in patients with advanced non–small cell lung cancer.
Tucatinib Triplet Improves Survival in Advanced HER2+ Breast Cancer
October 21st 2019Tucatinib combined with trastuzumab and capecitabine improved overall survival and progression-free survival compared with trastuzumab/capecitabine alone in heavily pretreated patients with locally advanced unresectable or metastatic HER2-positive breast cancer.
Atezolizumab/Bevacizumab Combo Improves Survival in Frontline HCC
October 21st 2019The combination of atezolizumab and bevacizumab showed statistically significant and clinically meaningful improvements in both progression-free and overall survival compared with sorafenib in patients with unresectable hepatocellular carcinoma who have not received prior therapy, meeting the coprimary endpoints of the IMbrave150 trial.
EU Panel Backs Pembrolizumab Regimens for Frontline HNSCC
October 18th 2019The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of pembrolizumab as a monotherapy or in combination with platinum and 5-FU as frontline treatment for patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma and PD-L1 expression on their tumors.
FDA Label Update Supports Earlier Use of Romiplostim for ITP
October 18th 2019The FDA has approved a supplemental Biologics License Application for romiplostim, updating its label to include data demonstrating sustained platelet responses in adults with immune thrombocytopenia. Romiplostim is approved for the treatment of adult patients with newly diagnosed or persistent who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Daratumumab Triplet Nears EU Approval for Frontline Transplant-Ineligible Myeloma
October 18th 2019The European Medicines Agency's Committee for Medicinal Products for Human Use has backed approval of daratumumab for use in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.
Chemotherapy Triplet Elicits Encouraging Activity in Pancreatic Adenocarcinoma
October 17th 2019The addition of cisplatin to gemcitabine and nab-paclitaxel resulted in encouraging activity in patients with previously untreated advanced pancreatic cancer, despite not having demonstrated the prespecified number of complete responses to meet the primary endpoint of a phase Ib/II clinical trial (NCT01893801), according to findings published in JAMA Oncology.