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.

Masofaniten Plus Enzalutamide Shows Safety With Potentially Durable PSA Decreases in mCRPC

February 5th 2024

Christos Kyriakopoulos, MD, discusses key phase 1 results from the ongoing evaluation of masofaniten and enzalutamide in patients with mCRPC.

FDA Grants Fast Track Designation to UV1 Cancer Vaccine for Unresectable/Metastatic Mesothelioma

February 5th 2024

The UV1 cancer vaccine received fast track designation for use in combination with ipilimumab and nivolumab for patients with unresectable malignant pleural mesothelioma.

Why a Targeted Therapy is Better Than Immunotherapy for Some Patients with Inoperable Non-Small Cell Lung Cancer

February 5th 2024

Non-small cell lung cancer, with an EGFR mutation, tends not to respond well to immunotherapy treatments, including durvalumab.

Enasidenib Plus Venetoclax Yields High Response Rates Targeting IDH2 Mutations in R/R AML

February 5th 2024

The combination of the first-in-class inhibitor enasidenib plus venetoclax has generated excitement targeting IDH2 mutations in relapsed/refractory AML.

World Cancer Day Highlights Ways to Address Gaps in Care for Black Patients With Breast Cancer

February 4th 2024

World Cancer Day is held every year on February 4th, prompting individuals across the globe to expand awareness within cancer care.

Linvoseltamab Continues to Elicit Durable Efficacy in High-Risk Relapsed/Refractory Multiple Myeloma

February 3rd 2024

Hans Lee, MD, discusses updated data from the LINKER-MM1 study in heavily pretreated relapsed/refractory multiple myeloma.

Pirtobrutinib Continues to Show Safety, Activity in Covalent BTK Inhibitor–Pretreated R/R MCL

February 2nd 2024

Jonathon B. Cohen, MD, MS, expands on updated data from the BRUIN trial of pirtobrutinib in patients with relapsed BTK-exposed mantle cell lymphoma.

EMA Validates MAA for Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

February 2nd 2024

The MAA seeking the approval of tisotumab vedotin in select patients with recurrent or metastatic cervical cancer has been validated by the EMA.

FDA Grants Orphan Drug Designation to Efineptakin Alfa for Pancreatic Cancer

February 2nd 2024

Efineptakin alfa received an orphan drug designation from the FDA for use as a potential therapeutic option in patients with pancreatic cancer.

A-Plus Machine Learning Approach Displays Accurate Cancer Detection With Smaller Sample Amounts

February 2nd 2024

Investigators have developed a machine learning algorithm that could eventually facilitate earlier cancer detection via smaller blood draws.

EMA Accepts Marketing Authorization Application for Linvoseltamab in R/R Multiple Myeloma

February 2nd 2024

The EMA has accepted for review an MAA seeking the approval of linvoseltamab for use in select patients with relapsed/refractory multiple myeloma.

Lenvatinib/Pembrolizumab Maintained Beneficial Outcomes When Evaluated by Tumor Size in RCC

February 2nd 2024

Lenvatinib/pembrolizumab demonstrated efficacy irrespective of tumor burden in advanced renal cell carcinoma in the overall patient population of the phase 3 CLEAR study.

Elevated Blood Levels of NT-proBNP in Cancer Survivors Link With Higher Risks of Death

February 2nd 2024

Cancer survivors with elevated levels of NT-proBNP have a higher risk of death, according to an analysis conducted by Dana-Farber Cancer Institute.

Lonial Spotlights CAR T-Cell and Off-the-Shelf Treatments in Multiple Myeloma

February 2nd 2024

Sagar Lonial, MD, FACP, details how CAR T-cell therapies and off-the-shelf treatments are improving outcomes for patients with multiple myeloma.

Japanese Approval Sought for Enfortumab Vedotin Plus Pembrolizumab in Urothelial Cancer

February 1st 2024

A sNDA seeking approval of enfortumab vedotin plus pembrolizumab for first-line use in patients with urothelial cancer has been submitted to Japan’s MHLW.

SCO-101 Plus FOLFIRI Shows Signs of Efficacy in Metastatic Colorectal Cancer

February 1st 2024

The combination of SCO-101 and FOLFIRI resulted in tumor reduction and increased progression-free survival in patients with metastatic colorectal cancer.

Physician Expectations Regarding the FDA Approval Process May Differ From Reality

February 1st 2024

Sanket Dhruva, MD, MHS, details examining the perspectives of physicians regarding the FDA approval process for drugs and high-risk medical devices.

FDA Grants Priority Review to Afami-Cel BLA in Advanced Synovial Sarcoma

February 1st 2024

The FDA has accepted for priority review the BLA seeking the approval of afamitresgene autoleucel for the treatment of advanced synovial sarcoma.

FDA Grants Fast Track Designation to BST02 for Liver Cancer

February 1st 2024

The FDA has granted a fast track designation to the T-cell therapy BST02 for the treatment of patients with all forms of liver cancer.

SABCS 2023 Findings Build on Positive Momentum in HER2+ Breast Cancer

February 1st 2024

Expert oncologists in the field of breast cancer review data in HER2-positive early-stage and metastatic breast cancer.