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 Grants Priority Review to Tazemetostat in Follicular Lymphoma
February 14th 2020The FDA has granted a priority review designation to a supplemental new drug application for tazemetostat for the treatment of patients with relapsed/refractory follicular lymphoma who have received at least 2 prior lines of systemic therapy.
FDA Grants Priority Review to Cedazuridine/Decitabine for MDS and CMML
February 14th 2020The FDA has granted a priority review designation to a new drug application for cedazuridine plus decitabine for the treatment of adult patients with previously untreated intermediate- and high-risk myelodysplastic syndromes or chronic myelomonocytic leukemia.
Expert Highlights Latest Developments in Early and Locally Advanced Pancreatic Cancer
February 14th 2020Diane Simeone, MD, discusses recent data on neoadjuvant and adjuvant therapy for patients with locally advanced or resectable pancreatic cancer, and questions surrounding germline testing for earlier identification of this disease.
Value-Based Care With Two-Sided Risk a Preference in Upcoming Oncology Care Model
February 13th 2020Oncology practices that are participating in the Centers for Medicare & Medicaid Innovation’s Oncology Care Model are willing to take on two-sided risk with value-based care and shift from a fee-for-service approach.
CD19-Directed CAR-NK Cell Therapy Elicits Responses in Non-Hodgkin Lymphoma and CLL
February 13th 2020Treatment with a CD19-targeted CAR-natural killer–cell therapy led to a 73% objective response rate, including 7 complete responses, in patients with relapsed/refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia.
FDA Grants Priority Review to Liso-Cel in Large B-Cell Lymphoma
February 13th 2020The FDA has granted a priority review designation to a biologics license application for the anti-CD19 CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma after at least 2 prior therapies.
FDA Grants Priority Review to Tucatinib in HER2+ Breast Cancer
February 13th 2020The FDA has granted a priority review designation to a new drug application for tucatinib for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, following at least 3 prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant, or metastatic setting.
Ilixadencel Added to Sunitinib Shows Positive OS Trend in RCC
February 13th 2020The addition of the off-the-shelf cancer immune primer ilixadencel to sunitinib trended toward a benefit in overall survival compared with sunitinib alone as a first-line treatment for patients with newly diagnosed metastatic renal cell carcinoma.
NICE Recommends Against Frontline Pembrolizumab/Axitinib in Advanced RCC
February 13th 2020The United Kingdom’s National Institute for Health and Care Excellence has chosen to not recommend the combination of pembrolizumab and axitinib for use in treatment-naïve adult patients with advanced renal cell carcinoma.
Frontline Pembrolizumab/Chemo Combo Improves PFS in PD-L1+ Metastatic TNBC
February 12th 2020The frontline combination of pembrolizumab and chemotherapy significantly improved progression-free survival compared with chemotherapy alone in patients with metastatic triple-negative breast cancer whose tumors expressed PD-L1.
CTC Detection Linked to Relapse in Stage III Melanoma
February 12th 2020The presence of circulating tumor cell was found to be independently associated with relapse in patients with stage III melanoma, suggesting that CTC assessment may be useful in identify patients who are at risk for relapse and could benefit from adjuvant therapy.