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.
HER2-Enriched Subtype Predicts Response to Dual HER2 Blockade in Early Breast Cancer
April 10th 2017According to results from the PAMELA trial, women with the HER2-enriched subtype of early-stage, HER2-positive breast cancer were more likely to have a pathological complete response when treated with dual HER2-blockade.
Pembrolizumab Impresses in Heavily Pretreated Head and Neck Cancer
April 7th 2017Pembrolizumab has shown durable, clinically significant responses in patients with locally advanced head and neck cancer who are refractory to platinum-based chemotherapy and cetuximab, according to results from the single-arm, phase II KEYNOTE-055 study.
CAR T Cell Functionality Correlates With Outcomes, Offering a Biomarker for Response
April 4th 2017The flexibility of CAR T cells to perform multiple functions was associated with the level of clinical activity elicited for patients with advanced non-Hodgkin’s lymphoma, according to a retrospective analysis presented at the 2017 AACR Annual Meeting.
Alectinib Improves PFS in Phase III ALK+ NSCLC Trial
April 4th 2017In findings from the phase III ALUR trial, alectinib significantly improved progression-free survival compared with chemotherapy in patients with ALK-positive non-small cell lung cancer who had progressed following treatment with platinum-based chemotherapy and crizotinib (Xalkori).
FDA Grants Full Approval to Osimertinib for T790M+ NSCLC
March 31st 2017The FDA has granted a regular approval to osimertinib as a treatment for patients with metastatic EGFR T790M mutation-positive non–small cell lung cancer following prior treatment with an EGFR TKI, based on progression-free survival findings from the phase III AURA3 trial.
FDA Grants Priority Review to sBLA for Full Approval of Blinatumomab in ALL
March 30th 2017The FDA has granted a priority review to a supplemental biologics license application supporting the conversion of the accelerated approval of blinatumomab to a full approval as a treatment for patients with Philadelphia chromosome-negative relapsed/refractory B-precursor acute lymphoblastic leukemia.
FDA Grants Priority Review to CTL019 for ALL
March 30th 2017The FDA has granted a priority review designation to tisagenlecleucel-T as a treamtnet for pediatric and young adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia, making it the first CAR T-cell therapy to enter regulatory review.