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 Updates Obinutuzumab Frontline CLL Label
December 25th 2014The FDA has updated the label for obinutuzumab plus chlorambucil to include data from stage 2 of the phase III CLL11 study, which detailed an unprecedented improvement in progression-free survival compared with rituximab plus chlorambucil as a frontline treatment for patients with chronic lymphocytic leukemia.
Lackluster T-DM1 Results Surprise Perez
December 22nd 2014Researchers will dissect topline results from the MARIANNE trial in the coming weeks in an effort to understand why T-DM1 (ado-trastuzumab emtansine; Kadcyla) failed to triumph as a first-line treatment in the metastatic setting for patients with advanced HER2-positive breast cancer despite the promise of earlier findings
Dreams of Opening a Solo Practice Dwindling Says Survey of Future Docs
December 22nd 2014Only 10% of current medical students aspire to open up shop as a solo practitioner-a 50% drop since 2008. Last year, 17% of students surveyed said that solo practice was a consideration. On the other hand, those students who anticipate seeking employment with a large group practice or hospital has risen to 73%, as compared with 70% last year.
Frontline T-DM1 Results Disappointing in Phase III MARIANNE Trial
December 19th 2014Two HER2-targeting regimens anchored by T-DM1 (ado-trastuzumab emtansine; Kadcyla) failed to outperform the standard strategy in women with previously untreated advanced HER2-positive breast cancer in the MARIANNE trial, dealing a blow to efforts to move the drug into frontline settings.
FDA Approves Ramucirumab for NSCLC
December 12th 2014The FDA has approved the VEGFR-2 inhibitor ramucirumab (Cyramza) in combination with docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumor has progressed during or following treatment with platinum-based chemotherapy.
Race, Hospital, and Insurance Status Matters For Patients With Inoperable Stage I Lung Cancer
December 2nd 2014Despite the proven benefits of stereotactic body radiotherapy (SBRT) for patients with inoperable stage I non–small cell lung cancer (NSCLC), whether such patients are offered it depends on their race, insurance status, and the type of facility where they are being treated.
Protein Predicts Response to New Immunotherapy Drug
November 26th 2014The presence of an immune-suppressing protein in non-cancerous immune cells may predict how patients with different types of cancer respond to treatment, a multi-center phase I study using an investigational immune therapy drug has found.
FDA Extends Panobinostat Review Period for Multiple Myeloma
November 25th 2014The FDA has extended the review period for panobinostat (LBH589) in combination with bortezomib (Velcade) and dexamethasone for patients with previously treated multiple myeloma by 3 months, placing a new decision date in early 2015.
Juno CAR T Cell Therapy Receives Breakthrough Designation for ALL
November 24th 2014The chimeric antigen receptor (CAR) T cell therapy JCAR015 has received a breakthrough therapy designation from the FDA as a treatment for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).
Frontline T-DM1 on Horizon in Metastatic Breast Cancer
November 20th 2014Treatment with the antibody-drug conjugate T-DM1 (ado-trastuzumab emtansine; Kadcyla) has demonstrated promising clinical efficacy with lower toxicity across a variety of settings for patients with HER2-positive metastatic breast cancer when compared with standard therapies.