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 Breakthrough Designation to Debio 1143 in Frontline Head and Neck Cancer
February 27th 2020The FDA has granted a breakthrough therapy designation to Debio 1143, an inhibitor of apoptosis protein antagonist, for the treatment of patients with previously untreated, unresectable, locally advanced squamous cell carcinoma of the head and neck in combination with standard cisplatin-based concomitant fractionation chemoradiation therapy
Frontline Maintenance Niraparib Takes Step Toward EU Approval in Ovarian Cancer
February 27th 2020The European Medicines Agency has validated a Type II Variation for niraparib as a first-line maintenance treatment for patients with advanced ovarian cancer who have responded to platinum-based chemotherapy, regardless of biomarker status.
NICE Rejects Polatuzumab Vedotin Combo in Relapsed/Refractory DLBCL
February 27th 2020The United Kingdom’s National Institute for Health and Care Excellence has chosen not to recommend polatuzumab vedotin plus rituximab and bendamustine for use in adult patients with relapsed/refractory diffuse large B-cell lymphoma who cannot undergo hematopoietic stem cell transplant.
FDA Panel Narrowly Supports Ramucirumab/Erlotinib Combo in Frontline EGFR+ NSCLC
February 27th 2020The FDA's Oncologic Drugs Advisory Committee voted 6 to 5 in favor of intravenous ramucirumab injection for use in combination with erlotinib as a frontline treatment for patients with metastatic non–small cell lung cancer whose tumors harbor EGFR exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations.
Coronavirus and Cancer: What Oncologists Need to Know
February 27th 2020Infectious diseases are the second-leading cause of mortality in patients with cancer, whose immune systems are often compromised, so it is essential for providers to keep abreast of the latest developments in the management of coronavirus disease 2019.
FDA Approves Neratinib Combo for HER2+ Breast Cancer
February 26th 2020The FDA has approved a supplemental new drug application for neratinib in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting.
Gemtuzumab Ozogamicin Misses Early EFS Endpoint, as Phase III Study Continues in NPM1+ AML
February 26th 2020Gemtuzumab ozogamicin in combination with intensive induction therapy was associated with a higher early death rate compared with induction therapy alone in patients with NPM1-mutated acute myeloid leukemia.
Neoadjuvant and Adjuvant ADT With Dose-Escalated PRT Show Similar Outcomes in Prostate Cancer
February 26th 2020Neoadjuvant and concurrent androgen-deprivation therapy (ADT) with dose-escalated prostate radiotherapy (PRT) and concurrent and adjuvant ADT plus dose-escalated PRT were found to have no statistically significant differences in biochemical relapse-free survival in patients with localized prostate cancer, according to results of a phase III trial.
Breast Oncologists Aim to Address Key Unanswered Questions With Novel Research Efforts
February 26th 2020Experts from Virginia Cancer Specialists, Georgetown University, Dana-Farber Cancer Institute, and Johns Hopkins Medicine to provide insight on some of the pivotal research being conducted at their respective institutions.
CRM1 Emerges as a Potential Target in Osteosarcoma in Novel Drug Discovery Model
February 26th 2020Alexander Leandros Lazarides, MD, discusses the need for better drug discovery models in osteosarcoma and provides insight into a new personalized medicine pipeline that has the potential to redefine drug development in the field.
Randall Ruminates on Challenges With Treating Sarcomas in AYA Patients
February 25th 2020R. Lor Randall, MD, FACS, highlights the specific challenges faced by adolescent and young adult patients with sarcomas, the importance of promoting awareness of this issue, and the resources available to improve outcomes in this population.
FDA Accepts BLA for Subcutaneous Fixed-Dose Pertuzumab/Trastuzumab in HER2+ Breast Cancer
February 25th 2020The FDA has accepted a Biologics License Application for a fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase, administered by subcutaneous injection in combination with intravenous chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer.
Minimally Invasive Hysterectomy Shows Inferior Recurrence Rates in Early-Stage Cervical Cancer
February 24th 2020Patients with early-stage cervical cancer who undergo minimally invasive radical hysterectomy have an inferior rate of disease-free survival compared to women who undergo open abdominal radical hysterectomy.
FDA Accepts Niraparib Application for Frontline Maintenance in Ovarian Cancer
February 24th 2020The FDA has accepted a supplemental New Drug Application for niraparib for use as a frontline maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status.