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 Tisotumab Vedotin for Recurrent or Metastatic Cervical Cancer
April 9th 2021The FDA has granted a priority review to the biologics license application for tisotumab vedotin as a potential treatment for patients with recurrent or metastatic cervical cancer with progressive disease on, or following, chemotherapy.
Saif Shares Key Treatment Considerations for Advanced Pancreatic Cancer
April 9th 2021Wasif Saif, MD, discusses factors to consider when choosing a frontline treatment strategy in pancreatic cancer, highlights the hunt for helpful biomarkers of response to available options, and offers sequencing suggestions.
Pursuing PARP Beyond HRD+ Ovarian Cancer
April 9th 2021Hye Sook Chon, MD, teases out some of the differences between the data with PARP inhibitors in the frontline maintenance setting and shed light on ongoing research with combinations that could broaden their utility in patients with advanced ovarian cancer.
Abu-Zeinah Shares Next Steps for Research With Interferon-Alpha in Polycythemia Vera
April 9th 2021Now that interferon-alpha has been shown to prolong survival in patients with polycythemia vera, it is important that investigative efforts focus on developing a better understanding on the biology of the disease and the mechanisms by which the agent actually improves outcomes.
Pirtobrutinib Showcases Encouraging Activity in CLL, MCL, and Other B-Cell Malignancies
April 8th 2021Pirtobrutinib showcased encouraging efficacy with an acceptable safety profile in patients with chronic lymphocytic leukemia or small lymphocytic leukemia, mantle cell lymphoma, and Waldenström macroglobulinemia who previously received a BTK inhibitor.
Clinical Benefit of Ripretinib Expands as Investigators Consider Future Directions
April 8th 2021Encouraging efficacy data for ripretinib as a later-line therapy for patients with advanced gastrointestinal stromal tumor have investigators hypothesizing new approaches to derive even greater benefit with the agent.
Biomarkers Could Be Key in Bringing CDK4/6 Inhibitors to Adjuvant HR+/HER2- Breast Cancer
April 8th 2021Conflicting results regarding the benefit of adjuvant CDK4/6 inhibition in early-stage hormone receptor–positive, HER2-negative breast cancer have prompted many questions regarding patient selection and treatment duration, which many hope will be answered with ongoing biomarker research.
Adjuvant Pembrolizumab Demonstrates Superior DFS Over Placebo in Post-Nephrectomy RCC
April 8th 2021Single-agent pembrolizumab resulted in a significant improvement in disease-free survival when used as an adjuvant treatment in patients with renal cell carcinoma following nephrectomy or nephrectomy and resection of metastatic lesions, meeting the primary end point of the phase 3 KEYNOTE-564 trial.
Novel Agents Expand MDS Treatment Armamentarium After Years of Inactivity
April 8th 2021Amit K. Verma, MD, spotlights new agents that have entered the myelodysplastic syndrome treatment arsenal and novel combinations currently under exploration, as well as efforts that are showing promise in patients with acute myeloid leukemia.
FDA Recommends Termination of Phase 2 Trial Examining Immunotherapy ERC1671 in Glioblastoma
April 7th 2021The FDA has recommended the early termination of a phase 2 trial examining the cell-based immunotherapy ERC1671 in combination with granulocyte-macrophage colony-stimulating factor, cyclophosphamide, and bevacizumab in patients with glioblastoma.
FDA Grants Regular Approval to Sacituzumab Govitecan for TNBC
April 7th 2021The FDA has granted a regular approval to sacituzumab govitecan for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have previously received 2 or more systemic therapies, at least 1 of them for metastatic disease.
Weight-Based Dosing With Narsoplimab Is Recommended in HSCT-TMA
April 7th 2021Pharmacodynamic and pharmacokinetic modeling of the investigational MASP-2 inhibitor narsoplimab supported a weight-based dosing method for patients with hematopoietic stem cell transplant–associated thrombotic microangiopathy.
Matsen Spotlights Best Practices for Breast Cancer Surgery Amidst the COVID-19 Crisis
April 7th 2021The coronavirus disease 2019 pandemic had a tremendous impact on the surgical care of patients with breast cancer; practice patterns needed to be rapidly adjusted to continue to safely provide care during a time when resources were very limited.
FDA Approves New Cetuximab Dose in KRAS Wild-Type, EGFR-Expressing CRC, Head and Neck Cancer
April 7th 2021The FDA has approved a new biweekly dosing regimen of 500 mg/m2 as a 120-minute intravenous infusion for cetuximab (Erbitux) for patients with KRAS wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck.