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 Sought for Mirdametinib in NF1-PN

March 4th 2024

SpringWorks Therapeutics has initiated a new drug application for mirdametinib in neurofibromatosis type 1-associated plexiform neurofibromas.

A2B530 Receives FDA Orphan Drug Designation in CRC

March 4th 2024

The FDA has granted orphan drug designation to A2B530 for the treatment of select patients with colorectal cancer.

EMA Validates MAAs for Datopotamab Deruxtecan in NSCLC and HR+ Breast Cancer

March 4th 2024

MAAs for datopotamab deruxtecan in non–small cell lung cancer and hormone receptor–positive, HER2-negative breast cancer have been validated by the EMA.

Banerjee Discusses FDA Call for Secondary Malignancies Boxed Warning on CAR T-cell Therapies

March 4th 2024

Rahul Banerjee, MD FACP, discusses the FDA’s decision to add a class-wide boxed warning for secondary malignancies on all approved CAR T-cell therapies.

Approvals in 2023 Elevate the CRC, HCC, and Pancreatic Cancer Fields, Paving the Way for More to Come

March 3rd 2024

Katrina S. Pedersen, MD, MS, details how the treatment of patients with gastrointestinal malignancies is evolving and notes notable trials as well as approvals.

Neoadjuvant Tislelizumab Plus Axitinib Generates Responses in Locally Advanced ccRCC

March 2nd 2024

Neoadjuvant tislelizumab plus axitinib demonstrated clinical efficacy and safety in patients with nonmetastatic clear cell renal cell carcinoma.

Indirect Comparison Study Shows PFS Superiority for Zanubrutinib vs Acalabrutinib in CLL

March 1st 2024

An indirect comparison study in relapsed/refractory chronic lymphocytic leukemia demonstrated survival benefits with zanubrutinib vs acalabrutinib.

New Clinical Practice Guideline Provides Overview on Salvage Therapy’s Role in Prostate Cancer

March 1st 2024

The American Urological Association has released their 2024 clinical practice guideline on salvage therapy for prostate cancer.

FDA Approves Frontline Amivantamab Plus Chemo for EGFR Exon 20 Insertion+ NSCLC

March 1st 2024

The FDA has approved amivantamab plus chemotherapy for the frontline treatment of select patients with EGFR exon 20 insertion+ non–small cell lung cancer.

Avelumab Maintenance Proves Equally Effective in Real-World Urothelial Carcinoma Population

March 1st 2024

Frontline maintenance therapy with avelumab following platinum-based chemotherapy led to similar outcomes in routine clinical practice and the JAVELIN Bladder 100 trial in metastatic urothelial cancer.

Early Emavusertib Success in AML and MDS Continues to Build

March 1st 2024

Eric S. Winer, MD, discusses the mechanism of action of emavusertib and preliminary findings from the TakeAim Leukemia trial in acute myeloid leukemia.

Karmanos Cancer Institute Implements New Bar Code Validation Software for Clinical Trial Drugs

March 1st 2024

The new process checking system makes sure the right drugs are dispensed, improving patient safety.

Zevorcabtagene Autoleucel Wins Approval in China for R/R Multiple Myeloma

March 1st 2024

China’s NMPA has approved zevor-cel for the treatment of adult patients with relapsed/refractory multiple myeloma after at least 3 lines of therapy.

HIPEC Elicits Similar Complication Rates, PFS in FIGO Stage III and IV Ovarian Cancer

March 1st 2024

HIPEC was not associated with additional complications or worse survival in patients with FIGO stage IV ovarian cancer vs those with stage III disease.

President’s Cancer Panel Outlines Recommendations to Accelerate National Cancer Plan Progress

March 1st 2024

The President’s Cancer Panel has issued an initial assessment of the National Cancer Plan with recommendations to accelerate cancer care developments.

Molecular Correlates May Be Key in Unleashing the Full Potential of Immunotherapy in NSCLC

February 29th 2024

Ashish Saxena, MD, PhD, discusses the movement of targeted and immune therapies in non–small cell lung cancer treatment.

Orca-T Shows Feasibility as a Reduced-Intensity Transplant Strategy in Hematologic Malignancies

February 29th 2024

Robert S. Negrin, MD, discusses the use of Orca-T as a viable strategy for patients with hematologic malignancies undergoing allogeneic transplant.

Retrospective Study Suggests Large Proportion of EU-Approved Oncology Drugs Offer Minimal or No Added Benefit

February 29th 2024

Most oncology drugs approved by the EMA recover research and development costs within a few years, even if the drug is providing little added benefit.

SNB-101 Receives Orphan Drug Designation in Pancreatic Cancer

February 29th 2024

SNB-101, a novel polymer nanoparticle agent, has been granted orphan drug designation by the FDA for the treatment of patients with pancreatic cancer.

FDA Awards Fast Track Designation to IDP-023 for Non-Hodgkin Lymphoma and Myeloma

February 29th 2024

The FDA has granted fast track designation to IDP-023 for the treatment of patients with non-Hodgkin lymphoma and multiple myeloma