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.

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.

Updated CheckMate 649 Data Reinforce Nivolumab Plus Chemo as Frontline SOC in Advanced Gastric Cancers

February 1st 2024

Kohei Shitara, MD, discusses 4-year survival data of chemotherapy plus nivolumab in advanced gastric/GEJ cancer or esophageal adenocarcinoma.

Investigators Set to Explore Selinexor Monotherapy or Plus Ruxolitinib in JAK Inhibitor–Naive Myelofibrosis

January 31st 2024

Selinexor is under investigation as monotherapy and in combination with the JAK inhibitor ruxolitinib in patients with JAK inhibitor–naive myelofibrosis.

Ziftomenib Combos Show Early Safety, Activity in NPM1-Mutant and KMT2A-Rearranged AML

January 31st 2024

An acceptable safety profile and early evidence of clinical activity was observed with ziftomenib plus standard regimens in select patients with AML.

Garmezy Highlights Ongoing and Future Research Directions Across RCC Subtypes

January 31st 2024

Benjamin Garmezy, MD, provides an overview of recent data on immuno-oncology/TKI combination data in variant renal cell carcinoma.

KRAS G12C–Targeted Therapies May Move Earlier in the mCRC Treatment Sequence

January 31st 2024

Rona Yaeger, MD, discusses a study of second-line sotorasib plus panitumumab in patients with KRAS G12C–mutated colorectal cancer.

sBLA Submitted to FDA for Subcutaneous Daratumumab Plus VRd in Transplant-Eligible Multiple Myeloma

January 31st 2024

A sBLA seeking the approval of D-VRd for transplant-eligible patients with newly diagnosed multiple myeloma was submitted to the FDA.