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 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.
FDA Grants Maintenance Olaparib Priority Review for Ovarian Cancer
March 28th 2017The FDA has granted a priority review to a new drug application for olaparib (Lynparza) as a maintenance therapy in relapsed patients with platinum-sensitive ovarian cancer, according to AstraZeneca, the manufacturer of the PARP inhibitor.
In Prostate Cancer, Moderate Hypofractionation Could Be New Standard
March 28th 2017James B. Yu, MD, discusses results of a study on moderate hypofractionation in patients with prostate cancer, as well as recent data demonstrating how genomic testing can be helpful in postoperative treatment decision making.
FDA Approves Niraparib for Ovarian Cancer
March 27th 2017The FDA has approved the PARP inhibitor niraparib (Zejula) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
Researcher Describes Relationship Between Neoadjuvant Chemo and Readmission in Ovarian Cancer
March 27th 2017Emma Barber, MD, discusses the impact of neoadjuvant chemotherapy on readmission rates, and how the goal of lowering readmission rates in ovarian cancer may not always align with optimizing long-term outcomes.
Osimertinib Approved in China for EGFR T790M+ NSCLC
March 27th 2017The China Food and Drug Administration has approved osimertinib for the treatment of patients with locally-advanced or metastatic EGFR T790M-positive non-small cell lung cancer with progression following treatment with an EGFR tyrosine kinase inhibitor.
Findings From the SystHERs Real-World Study of HER2+ Breast Cancer
March 27th 2017Mohammad Jahanzeb, MD, discusses the SystHERs trial, which was designed to provide real-world insight into current treatment patterns, long-term survival, and patient experience with multiple different treatments for HER2-positive metastatic breast cancer.
Pembrolizumab Recommended for EU Approval in Hodgkin Lymphoma
March 25th 2017The EMA’s Committee for Medicinal Products for Human Use has recommended approval of pembrolizumab for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have progressed following autologous stem cell transplant and brentuximab vedotin, or who are transplant-ineligible and have failed brentuximab vedotin.