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.
Cures Act Moves Step Closer to Adoption With Senate Approval
December 8th 2016The sweeping, $6.3 billion 21st Century Cures Act, designed to create a 10-year pool of money for precision medicine development and social health initiatives, gained overwhelming Senate approval Wednesday and goes next to President Obama, who has said he will sign the bill.
TILs Associated With Survival for Advanced HER2+ Breast Cancer
December 8th 2016Higher levels of tumor-infiltrating lymphocytes were associated with improvements in overall survival for patients with advanced HER2-positive breast cancer treated with docetaxel, trastuzumab, and pertuzumab in the phase III CLEOPATRA trial.
Rituximab Maintenance Prolongs Survival in Younger MCL Patients
December 5th 2016Younger patients with mantle cell lymphoma lived significantly longer and without disease progression or clinical events when they received rituximab maintenance therapy after stem cell transplantation, final results of a randomized trial showed.
Passed by House, 21st Century Cures Act Could Spur Advances, Weaken FDA
December 2nd 2016Viewed by some as a boon for precision medicine, an Alzheimer’s cure, brain research, and opioid abuse prevention, but also seen as weakening the FDA’s regulatory power, the $6.3 billion 21st Century Cures Act passed overwhelmingly in the House Wednesday by a vote of 392-26.
FDA Grants Pembrolizumab Priority Review for Hodgkin Lymphoma
December 1st 2016The FDA has granted a priority review to a supplemental biologics license application for pembrolizumab for use as a treatment for patients with refractory classical Hodgkin lymphoma or those who have relapsed after ≥3 lines of therapy,
Sanofi's Halt of BCG Production Worries Bladder Cancer Patients and Urologists
December 1st 2016Sanofi Pasteur plans to discontinue production of Bacillus Calmette-Guérin for the US market by mid-2017, startling physicians and patients who fear that a shortage of the widely used bladder cancer therapy will develop.
FDA Grants Ponatinib Full Approval for Rare Leukemias
November 29th 2016The FDA has granted a full approval and label update to ponatinib for patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor therapy is indicated, as well as for patients with T315I-positive CML or T315I-positive Ph+ ALL.
Taking Steps to Manage Adverse Events Associated with Checkpoint Inhibitors
November 29th 2016The observed adverse events that have been associated with immunotherapy, especially immunotherapy combinations, have to be properly assessed against their clearly improved efficacy in patients with otherwise dismal prognosis from stage IV cancers.
Lead PALOMA-2 Author Says Results Will Boost Global Use of Palbociclib
November 28th 2016Results from the phase III PALOMA-2 study—which demonstrated a significant progression-free survival advantage with palbociclib (Ibrance) plus letrozole compared with letrozole alone in ER-positive, HER2-negative metastatic breast cancer—were recently published in The New England Journal of Medicine.
TKI Sequencing in RCC Will Bring in New Paradigms, Outcomes
November 27th 2016In the past decade, the addition of tyrosine kinase inhibitors has had a huge impact on the treatment of renal cell carcinoma in the first- and second-line settings. Currently available agents include sorafenib, sunitinib, pazopanib, axitinib, and the recently-added cabozantinib, and lenvatinib.
COA Declares Early Victory in CMS Part B Payment Battle
November 24th 2016The change of administrations in Washington, DC may undermine the future of a proposal to revise Medicare Part B drug compensation, a plan that has been widely criticized in the oncological community because of the potential reduction in profit margins it entails.