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 Adjuvant Dabrafenib/Trametinib Priority Review for BRAF+ Melanoma
December 22nd 2017The FDA has granted a priority review to a supplemental new drug application for the use of dabrafenib combined with trametinib as an adjuvant treatment for patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.
Ropeginterferon Alfa-2b Demonstrates Durable Activity in Polycythemia Vera
December 21st 2017Two-year findings from the follow-up phase III CONTI-PV randomized trial showed that ropeginterferon alfa-2b, a novel pegylated formulation of interferon alfa-2b, reached a significantly higher rate of complete hematologic response versus hydroxyurea in patients with polycythemia vera.
$1.5 Trillion Tax Plan Heads to White House for Signature
December 21st 2017The consolidated tax bill that now goes to President Trump’s desk for a signature carries with it dire warnings from oncology interest groups that access to care will suffer under the federal spending cutbacks that are expected to result.
NICE Recommends Approval for Ribociclib, Palbociclib for HR+/ HER2- Advanced Breast Cancer
December 21st 2017The United Kingdom's National Institute for Health and Care Excellence has issued guidance supporting approval for ribociclib and palbociclib for patients with hormone receptor-positive/HER2-negative locally advanced or secondary breast cancer.
Daratumumab Regimen Maintains Favorable Performance in Relapsed/Refractory Myeloma
December 21st 2017Progression-free survival remained superior over time in patients with relapsed/refractory multiple myeloma treated treated with combination therapy that included the anti-CD38 antibody daratumumab (Darzalex).
Larotrectinib Rolling NDA Submission Initiated for TRK+ Cancers
December 20th 2017Loxo Oncology has initiated a rolling submission of data for a NDA to the FDA for the novel pan-TRK inhibitor larotrectinib (LOXO-101) as a treatment for adult and pediatric patients with TRK fusion-positive advanced solid tumors.
Checkpoint Inhibitors, TKIs, and Novel Agents Poised to Enter Liver Cancer Treatment Paradigm
December 19th 2017Ghassan K. Abou-Alfa, MD, discusses what he sees coming down the pike in epatocellular carcinoma with regard to novel agents, including CAR T-cell therapy, and the burgeoning questions with optimal sequencing of these treatments.
HPV 16/18 Linked to Increased Relapse Risk in Cervical Cancer
December 19th 2017Persistent HPV 16/18 infection correlated with higher locoregional relapse, overall relapse, and was also associated with early relapses in women with locally advanced cervical cancers treated with radical radiochemotherapy.
CHMP Issues Positive Opinion on Herzuma for HER2+ Breast, Gastric Cancers
December 19th 2017The European Union’s CHMP has delivered a positive opinion for Herzuma (CT-P6), a trastuzumab (Herceptin) biosimilar in HER2-positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.