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 Approval Is Sought for PredicineCARE Assay as Companion Diagnostic in Bladder Cancer

September 3rd 2025

The first part of a PMA seeking the approval of PredicineCARE as a companion diagnostic in bladder cancer was submitted to the FDA.

Zanzalintinib Plus Nivolumab Generates Early Antitumor Activity in Untreated Advanced ccRCC

September 3rd 2025

Jad Chahoud, MD, MPH, discusses preliminary efficacy data with zanzalintinib plus nivolumab with/without relatlimab in untreated, advanced clear cell RCC.

Understanding Your New Role as a Hematology/Oncology Fellow

September 3rd 2025

The chief oncology/hematology fellow at Weill Cornell Medicine details everything that he wishes he had known entering his first year of fellowship.

OncLive’s August EMA Regulatory Recap: Key EU Approvals in Oncology

September 3rd 2025

Here is your snapshot of all oncologic therapeutic options that were approved by the EMA in August 2025.

Development to Discontinue for ZW171 in Gynecologic, Thoracic, and GI Cancer

September 2nd 2025

The development of ZW171 for gynecologic, thoracic, and GI cancers is being discontinued.

NALIRIFOX Expands Options in First-Line Metastatic Pancreatic Cancer

September 2nd 2025

Raji Shameem, MD, discusses the significance of the FDA approval of NALIRIFOX and first-line treatment selection in metastatic pancreatic cancer.

Rilzabrutinib Nets Approval in Pretreated Immune Thrombocytopenia

September 2nd 2025

Rilzabrutinib has been approved by the FDA for persistent or chronic immune thrombocytopenia after an insufficient response to prior therapy.

Roswell Park’s Pediatric Stem Cell Transplant Program Again Designated by Optum as Center of Excellence

September 2nd 2025

Health services company recognizes joint care offered through collaboration with Roswell Park Oishei Children’s Hospital.

FDA Grants Type A Meeting to Discuss RP1 Plus Nivolumab in Advanced Melanoma

September 2nd 2025

The FDA scheduled a Type A meeting with the developer of RP1 to discuss the CRL that was granted to RP1 plus nivolumab for advanced melanoma.

Zongertinib Earns Chinese Approval for Unresectable, Locally Advanced, HER2-Mutant NSCLC

September 2nd 2025

China’s NMPA approved zongertinib tablets for unresectable, locally advanced or metastatic, previously treated NSCLC with HER2 mutations.

FDA Approves New Denosumab Biosimilars for Osteoporosis and Cancer-Related Bone Disease

September 2nd 2025

OncLive’s August Roundup of Key FDA Approvals in Oncology: 3 Decisions to Know

September 2nd 2025

Here is your guide to all therapeutic options that were cleared by the FDA in August 2025 spanning tumor types.

How Fellows Can Leverage Mentorship to Maximize Research Opportunities

September 2nd 2025

The director of the Hematology and Oncology Fellowship Program at Weill Cornell Medicine details how fellows can identify and maximize research opportunities.

TT125-802 Earns FDA Fast Track Designations for EGFR+ and KRAS G12C+ Advanced NSCLC

September 1st 2025

TT125-802 has received FDA fast track designations in EGFR+ and KRAS G12C+ advanced NSCLC.

New Strategy for Small Cell Lung Cancer Treatment Emerges from Dana-Farber Science

September 1st 2025

Dana-Farber researchers have provided the mechanistic and preclinical evidence needed to support a clinical trial of a new class of drugs called direct cyclin inhibitors in patients with a range of cancers.

EMA Grants Orphan Drug Designation to OXC-101 for Acute Myeloid Leukemia

September 1st 2025

The European Medicines Agency has granted orphan drug designation to OXC-101 for the treatment of acute myeloid leukemia.

Revisit Every OncLive On Air Episode From August 2025

September 1st 2025

In case you missed any, below is a recap of every OncLive On Air episode that aired in August 2025.

Five Under 5: Top Oncology Videos for the Week of 8/24

August 31st 2025

The top 5 OncLive videos of the week cover insights in lung cancer, ovarian cancer, breast cancer, and prostate cancer.

FDA Grants Breakthrough Device Designation to Haystack MRD ctDNA Liquid Biopsy for Stage II CRC

August 31st 2025

The FDA granted breakthrough device designation to the Haystack MRD ctDNA liquid biopsy for stage II colorectal cancer.

The OncFive: Top Oncology Articles for the Week of 8/24

August 30th 2025

The FDA has cleared a 3-month subcutaneous depot formulation of leuprolide mesylate in prostate cancer, gedatolisib NDA is under review in breast cancer, and more.