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 Balstilimab for Recurrent or Metastatic Cervical Cancer
June 17th 2021The FDA has granted priority review to the biologics license application for balstilimab for use in the treatment of patients with recurrent or metastatic cervical cancer who experienced disease progression on, or after, chemotherapy.
Landgren Spotlights Safety Considerations for Carfilzomib Quadruplet in Newly Diagnosed Myeloma
June 17th 2021C. Ola Landgren, MD, PhD, discusses key safety considerations with a novel carfilzomib quadruplet regimen in patients with newly diagnosed multiple myeloma, the clinical implications of the phase 2 MANHATTAN trial, and next steps for this research.
Hoffman Highlights Key Updates in Rapidly Evolving Multiple Myeloma Care Continuum
June 17th 2021Quadruplet regimens, such as those with daratumumab, are on the rise in the frontline treatment of patients with multiple myeloma, and the FDA approval of the first BCMA-targeted CAR T-cell therapy idecabtagene vicleucel represents the monumental advance made in the relapsed/refractory setting.
Landgren Lauds Promise of Carfilzomib Quadruplet Regimen in Newly Diagnosed Myeloma
June 16th 2021C. Ola Landgren, MD, PhD, discusses important research efforts that led to the launch of the phase 2 MANHATTAN trial, the results achieved with the weekly carfilzomib quadruplet regimen in patients with newly diagnosed multiple myeloma, and the potential for this approach irrespective of transplant eligibility status.
FDA Approves Avapritinib for Advanced Systemic Mastocytosis
June 16th 2021The FDA has approved avapritinib (Ayvakit) for the treatment of adult patients with advanced systemic mastocytosis, including those with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, and mast cell leukemia.
LiPax Elicits Encouraging RFS Rate in Non–Muscle Invasive Bladder Cancer
June 16th 2021LiPax, a precision-targeted, locally-delivered taxane, was found to induce a recurrence-free survival rate of 83% in patients with non–muscle invasive bladder cancer who had undergone transurethral resection of bladder tumor.
Precision Medicine Presents a Disconnect in Oncology Practice
June 16th 2021Multiple FDA approvals and an increasing number of clinical trials examining molecular target–based therapeutics, including second- or even third-generation drugs against a well-defined target, present an ever-widening array of drugs for routine cancer care based on the discovery of specific molecular targets within the tumor or within the germline.
CD20-Targeting Antibodies Are Shaping a New Landscape for B-Cell Cancers
June 16th 2021Among the pioneering targets for antibody therapy was CD20, the pursuit of which ultimately led to the first FDA-approved mAb for cancer therapy, rituximab, and defined a new era in the management of B-cell malignancies.
Investigators Set Sights on Curative Approaches for Follicular Lymphoma
June 15th 2021The majority of patients with indolent follicular lymphoma do well with observation and after first-line treatment, but approximately 20% experience disease progression within 2 years of their initial treatment, which is associated with a 50% risk of dying within 5 years. Subsequently, this is an area of unmet need but one in which considerable progress is being made.
Kaiku Health and Novartis Collaborate on Specialized Digital Patient Monitoring Technology
June 15th 2021Kaiku Health has announced that they are partnering with the global healthcare company Novartis to develop a digital patient monitoring and management system specifically for patients with melanoma who are receiving BRAF/MEK combination therapies.
Burgeoning Breast Cancer Landscape Brings Hope for a Brighter Future
June 15th 2021The expansion of HER2-directed treatments and formulations, the availability of CDK4/6 inhibitors, and the broad activity of sacituzumab govitecan-hziy is a testament to the successful development of personalized medicine in breast cancer.
The Next Chapter in RCC Recontextualizes Treatment Considerations
June 15th 2021Renal cell carcinoma is one of the top 10 most common cancers, although incidence rates have been stable over the past decade. It is more common in men than women and rates are higher among African American, American Indian, and Alaska Native patient populations.
eMonarcHER to Examine Abemaciclib Plus Adjuvant Endocrine Therapy in HER2+ Early Breast Cancer
June 14th 2021The safety and efficacy of abemaciclib will be examined in patients with hormone receptor–positive, HER2-positive, node-positive, high-risk early breast cancer who have completed standard adjuvant HER2-targeted treatment as part of the phase 3 eMonarcHER trial.
Rituximab Biosimilar CT-P10 Demonstrates Real-World Safety, Efficacy in DLBCL
June 14th 2021The rituximab biosimilar CT-P10 produced response and survival rates that were comparable to those previously reported with the reference product, along with acceptable tolerability, in patients with diffuse large B-cell lymphoma.
Frontline Trastuzumab Deruxtecan Under Exploration With or Without Pertuzumab in HER2+ Breast Cancer
June 14th 2021Fam-trastuzumab deruxtecan-nxki is under investigation with or without pertuzumab vs a standard-of-care regimen comprised of a taxane, trastuzumab, and pertuzumab in the frontline treatment of patients with HER2-positive metastatic breast cancer as part of the phase 3 DESTINY-Breast09 trial.
Adjuvant Nivolumab Improves DFS in High-Risk Muscle-Invasive Urothelial Cancer
June 14th 2021Adjuvant nivolumab led to a significant improvement in disease-free survival compared with placebo in patients with high-risk muscle-invasive urothelial carcinoma following radical surgery, irrespective of PD-L1 expression level.