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.
Lenalidomide Shows Activity in Low-Risk MDS
December 22nd 2016Results from the randomized phase II HOVON89 trial showed that nearly 40% of patients with low intermediate-1 risk myelodysplastic syndrome who were refractory to erythropoietin and granulocyte-colony stimulating factor experienced hematologic improvement with erythroid response after being treated with lenalidomide monotherapy.
Concomitant Chemo Regimens Most Effective for Locally Advanced Nasopharyngeal Carcinoma
December 22nd 2016The addition of chemotherapy, either adjuvant or induction, to concomitant chemoradiotherapy achieved a significantly high survival benefit for patients with locally advanced nasopharyngeal carcinoma.
FDA Grants Priority Review to sNDA for Full Approval of Palbociclib in Breast Cancer
December 22nd 2016The FDA has granted a priority review to a supplemental new drug application supporting the conversation of the accelerated approval of palbociclib (Ibrance) to a full approval for use in combination with letrozole as a frontline treatment for postmenopausal women with ER-positive, HER2-negative metastatic breast cancer.
FDA Grants Marketing Approval to AeroForm Tissue Expansion Device for Patients Following Mastectomy
December 22nd 2016The FDA has approved the marketing of AeroForm, a new system for soft tissue expansion in 2-stage breast reconstruction following mastectomy, and in the treatment of underdeveloped breasts and soft tissue deformities.
MM-302 Falls Short in Phase II HER2+ Breast Cancer Trial
December 21st 2016The phase II HERMIONE trial was halted after the antibody-drug conjugate MM-302 combined with trastuzumab failed to improve progression-free survival versus chemotherapy plus trastuzumab in patients with HER2-positive metastatic breast cancer who had previously received trastuzumab, pertuzumab, and ado-trastuzumab emtansine.
FDA Grants Niraparib Priority Review in Ovarian Cancer
December 20th 2016The FDA has granted a priority review to a new drug application for the PARP 1/2 inhibitor niraparib for use as a maintenance therapy in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have responded to platinum-based chemotherapy.
In Head and Neck Cancer, a Stepped Approach to Psychosocial Care Is Cost-Effective
December 20th 2016Patients diagnosed with head and neck or lung cancer are especially prone to feelings of distress, especially depression, and researchers in the Netherlands have found that using a gradual or “stepped” approach to providing psychosocial support not only improves their quality of life but is also cost-effective.
Axillary Lymph Node Dissection Can Be Avoided for Some Patients With Breast Cancer, Study Shows
December 19th 2016Results of a clinical trial show that an axillary lymph node dissection can be avoided for patients with large, operable tumors in the breast, no clinical signs of cancer in the axillary nodes before being treated with neoadjuvant chemotherapy, and no signs of cancer following a sentinel lymph node biopsy during surgery.
Coroner's Report: Part B Payment Model Is Dead
December 17th 2016CMS and Rep. Nancy Pelosi (D-CA) have confirmed the demise of the Medicare Part B Drug Payment Model "experiment" to cut margins paid to physicians on some of the most expensive drugs and introduce private sector thinking into drug purchasing and pricing systems.
Frontline Pembrolizumab Receives Positive CHMP Opinion for PD-L1+ NSCLC
December 17th 2016The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of frontline pembrolizumab for the treatment of patients with metastatic non–small cell lung cancer whose tumors do not harbor EGFR or ALK mutations.
ABIM Will Offer 2-Year "Knowledge Check-in" Test for MOC
December 16th 2016After 2 years of reflecting on feedback from the medical community, the American Board of Internal Medicine has developed a new iteration of its Maintenance of Certification testing that it hopes will satisfy the needs of physicians.
Continuous Low-Dose Ribociclib Both Safe and Active in Advanced Breast Cancer
December 16th 2016A continuous low-dose of ribociclib demonstrated both preliminary activity and an acceptable safety profile when compared with an intermittent dose of ribociclib when combined with fulvestrant in the treatment of postmenopausal patients with hormone receptor-positive, HER2-negative advanced breast cancer.
Addition of Daratumumab Triples Increase in MRD Conversion in Relapsed Myeloma
December 16th 2016The addition of daratumumab to standard-of-care regimens tripled the increase in conversion to negative minimal residual disease status in the treatment of patients with relapsed/refractory multiple myeloma.