All Oncology News

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 Luspatercept for First-line Treatment of Anemia in Lower-risk MDS

May 1st 2023

The FDA has granted a priority review to the supplemental biologics license application seeking to expand the current indication of luspatercept to include treatment of anemia in patients with very low- to intermediate-risk myelodysplastic syndrome who have not previously received erythropoiesis-stimulating agents and who may require red blood cell transfusions.

Pembrolizumab Monotherapy Demonstrates Clinical Efficacy in High-risk NMIBC

May 1st 2023

Treatment with pembrolizumab monotherapy resulted in stable long-term disease-free survival rates in patients with Bacillus Calmette-Guérin–unresponsive, high-risk non–muscle-invasive bladder cancer.

TAR-200 Produces High CR Rates, Tolerability in BCG-unresponsive NMIBC

May 1st 2023

Treatment with TAR-200 produced complete responses and was well tolerated in patients with Bacillus Calmette-Guérin–unresponsive, high-risk non–muscle-invasive bladder cancer, according to preliminary data from the phase 2b SunRISe-1 trial.

FDA Approves xT CDx, a NGS-Based in Vitro Diagnostic Device

May 1st 2023

The FDA has approved xT CDx, a 648-gene next-generation sequencing assay for solid tumor profiling, and companion diagnostic for patients with colorectal cancer.

Nivolumab Maintains DFS Benefit in MIUC and MIBC After Radical Surgery

May 1st 2023

Nivolumab following radical surgery continued to display a benefit in disease-free survival in patients with muscle-invasive urothelial carcinoma and muscle-invasive bladder cancer.

Sintilimab Plus Axitinib Has Clinical Efficacy in Advanced FH-Deficient RCC

April 30th 2023

Treatment with sintilimab in combination with axitinib resulted in tumor shrinkage with tolerable adverse effects in patients with advanced fumarate hydratase–deficient renal cell carcinoma.

Complications Following Partial Nephrectomy Associated With Particular Comorbidities in RCC

April 30th 2023

Specific comorbidities were linked with complications following partial nephrectomy, compared with radical nephrectomy, in patients with T1b to T2 renal cell carcinoma.

Hypertension Linked With Worse Outcomes for Patients With Upper Tract Urothelial Cancer Undergoing Nephroureterectomy

April 30th 2023

Hypertension was found to be an independent risk factor for worse survival outcomes in patients with upper tract urothelial cancer undergoing radical nephroureterectomy.

High BMI Associated With Longer OS in Patients With RCC Undergoing Nephrectomy

April 30th 2023

A high body mass index was linked with improved overall survival in patients with renal cell carcinoma undergoing radical nephrectomy.

Dr Lowentritt on PSA Response and Time to Castration Resistance in mCSPC

April 29th 2023

Benjamin H. Lowentritt, MD, FACS, discusses prostate-specific antigen response and time to castration resistance in patients with metastatic castration-sensitive prostate cancer started on apalutamide, enzalutamide, or abiraterone acetate.

Enzalutamide With or Without Leuprolide Offers MFS Benefit Vs Leuprolide Alone in nmHSPC With High-risk BCR

April 29th 2023

Treatment with the androgen receptor inhibitor enzalutamide plus leuprolide led to a significant reduction in the risk of metastasis or death compared with placebo plus leuprolide in patients with nonmetastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence.

Apalutamide Demonstrates Robust Real-World Effectiveness in mCSPC

April 29th 2023

Patients with metastatic castration-sensitive prostate cancer treated with the androgen receptor–signaling inhibitor apalutamide achieved prostate-specific antigen responses that trended higher and rates of progression to castration resistance that trended lower than those receiving enzalutamide or abiraterone acetate/

Darolutamide Plus ADT/Docetaxel Produces Durable PSA Responses in mHSPC

April 29th 2023

A post-hoc analysis of the phase 3 ARASENS trial demonstrated that the addition of darolutamide to androgen deprivation therapy and docetaxel produced deep and durable prostate-specific antigen responses in patients with metastatic hormone-sensitive prostate cancer.

Darolutamide Plus ADT Elicits OS Benefit in North American Patients With mHSPC

April 29th 2023

A subgroup analysis of the phase 3 ARASENS trial showed that darolutamide plus androgen deprivation therapy elicited an overall survival benefit in North American patients with metastatic hormone-sensitive prostate cancer.

Phase 2 Data Show Clinical Activity With CG0070 Plus Pembrolizumab in NMIBC

April 29th 2023

Cretostimogene grenadenorepvec in combination with pembrolizumab produced high complete response rates with a tolerable safety profile in patients with Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.

Darolutamide Associated With Lower Rates of Treatment Discontinuation and Disease Progression in nmCRPC

April 29th 2023

Treatment with darolutamide was associated with lower rates of discontinuation and progression to metastatic disease compared with enzalutamide and apalutamide in patients with nonmetastatic castration-resistant prostate cancer.

Long-Term JAVELIN Bladder 100 Data Support Avelumab Maintenance in Advanced Urothelial Carcinoma

April 28th 2023

First-line avelumab maintenance therapy prolonged survival in patients with advanced urothelial carcinoma, regardless of response to first-line chemotherapy, according to findings from an exploratory subgroup analysis of the phase 3 JAVELIN Bladder 100 trial.

68Ga-FAP-2286 PET Imaging Influences Bladder Cancer Treatment Decisions

April 28th 2023

The use of 68Ga-FAP-2286 PET imaging may improve treatment selection and response assessment in patients with bladder cancer, according to findings from a pilot study evaluating the diagnostic performance of this imaging technology.

FDA Panel Votes Proposed Olaparib/Abiraterone Indication Should Be Restricted to BRCA-Mutant mCRPC

April 28th 2023

In an 11-to-1 vote, the FDA’s Oncologic Drugs Advisory Committee voted that the proposed indication of olaparib in combination with abiraterone acetate and prednisone or prednisolone for the initial treatment of patients with metastatic castration-resistant prostate cancer should be restricted to those whose tumors harbor a BRCA mutation.

Frontline Olaparib Plus Abiraterone Reduces PSA Levels, Delays Time to PSA Progression in mCRPC

April 28th 2023

The addition of olaparib to abiraterone acetate resulted in numerically higher prostate-specific antigen response rates and prolonged time to PSA progression vs abiraterone alone when used in the frontline treatment of patients with metastatic castration-resistant prostate cancer.