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.
Prognostic Factors Link to Longer OS With MEK/BRAF Combo in Melanoma
June 2nd 2016A long-term analysis has shown that approximately one-fifth of patients with BRAF V600-mutant melanoma who were treated with the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) remained progression-free after 3 years, suggesting a plateau of the survival curve.
Expert Sheds Light on Role of Next-Generation Agents in CLL
June 1st 2016Susan M. O'Brien, MD, discusses upcoming novel treatments in relapsed/refractory chronic lymphocytic leukemia, such as the next generation of inhibition with BTK, SYK, and PI3K, as well as the outcomes of the recent RESONATE-2 trial.
CHMP Backs New Brentuximab Vedotin Indication for Hodgkin Lymphoma
May 28th 2016The EMA's Committee for Medicinal Products for Human Use has granted a positive opinion to brentuximab vedotin (Adcetris) for use as a consolidation therapy following autologous stem cell transplantation in patients with CD30-positive Hodgkin lymphoma at risk of relapse or progression.
CHMP Recommends Expanding Carfilzomib Approval in Multiple Myeloma
May 27th 2016Carfilzomib (Kyprolis) has received a positive recommendation from the EMA's Committee for Medicinal Products for Human Use for use in combination with dexamethasone alone as a treatment for patients with multiple myeloma following at least 1 prior therapy.
FDA Approves Radioactive Imaging Agent Axumin in Recurrent Prostate Cancer
May 27th 2016The radioactive imaging agent, fluciclovine F18 (Axumin), was approved by the FDA for use in positron emission tomography scans in men with suspected recurrence of prostate cancer whose prostate-specific antigen levels rise following prior treatment.
Gene Expression Signature Predicts Hormonal Resistance in Prostate Cancer
May 24th 2016Using the Decipher Prostate Cancer Classifier assay to predict which patients might respond to hormonal therapy has resulted in the discovery and validation of an adjuvant androgen-deprivation therapy resistance signature.
Daratumumab Approved in Europe for Multiple Myeloma
May 23rd 2016The European Commission has granted conditional marketing approval to daratumumab (Darzalex) for the treatment of patients with relapsed/refractory multiple myeloma previously treated with a proteasome inhibitor and an immunomodulatory agent who progressed on their last therapy.
IHC Staining Found Effective for ROS1+ NSCLC
May 22nd 2016The use of immunohistochemistry could be a more cost- and time-efficient first-line screening method for identifying ROS1 gene rearrangements to predict eligibility for crizotinib (Xalkori) for patients with non–small cell lung cancer compared with fluorescence in-situ hybridization.