All Oncology News

Imetelstat Provides Durable Transfusion Independence in Lower-Risk MDS

January 4th 2023

Significant and durable transfusion independence was achieved with imetelstat vs placebo in patients with lower-risk myelodysplastic syndromes who were relapsed, refractory, or ineligible for erythropoiesis-stimulating agents, meeting the primary and a key secondary end point of the phase 3 IMerge trial.

FDA Approval Sought for Cosibelimab in Advanced Cutaneous Squamous Cell Carcinoma

January 4th 2023

A biologics license application has been submitted to the FDA seeking the approval of cosibelimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation.

FDA Grants Breakthrough Device Designation to OverC Multi-Cancer Detection Blood Test

January 4th 2023

The FDA has granted a breakthrough device designation to the OverC Multi-Cancer Detection Blood Test for the early detection of cancers including esophageal, liver, lung, ovarian, and pancreatic in adults aged to 50 to 75 years with average risk.

HPV, PD-L1 Move to the Forefront of Biomarkers for Head and Neck Cancers

January 4th 2023

HPV status has broad applicability across head and neck cancers, whereas the clinical utility of PD-L1 expression remains a more nuanced question.

FDA Grants Breakthrough Device Designation for Blood Test for Inaccessible Brain Tumors

January 4th 2023

The FDA has granted breakthrough device designation for the TriNetra™-Glio blood test to help in the diagnosis of brain tumors.

EMA Validates Type II Application for Trastuzumab Deruxtecan in Advanced HER2-Mutated NSCLC

January 4th 2023

The European Medicines Agency has validated an application for the use of trastuzumab deruxtecan for adults with previously treated unresectable or metastatic non–small cell lung cancer whose tumors have activating HER2 mutations.

N-803 Plus BCG Generates Strong, Durable Response in Non–Muscle Invasive Bladder Cancer

January 4th 2023

N-803, a novel IL-15 superagonist, in combination with intravesical Bacillus Calmette–Guérin induced an overall response in more than two-thirds of patients with non–muscle invasive bladder cancer.

EMA Committee Advises Against Approval of Omburtamab for Neuroblastoma

January 3rd 2023

The European Committee for Medicinal Products for Human Use has announced that it does not support the marketing authorization of omburtamab for the treatment of patients with central nervous system/leptomeningeal metastasis from neuroblastoma.

Mirvetuximab Soravtansine Accelerated Approval Helps Fill Unmet Need in Platinum Resistant Ovarian Cancer

January 3rd 2023

Ursula A. Matulonis, MD, discusses the novelty of mirvetuximab soravtansine in platinum-resistant ovarian cancer, and how it will expand options for a traditionally difficult-to-treat population.

Glofitamab Plus R-CHOP Displays Tolerable Safety Profile in Treatment-Naïve DLBCL

January 3rd 2023

Max S. Topp, MD, highlights the rationale for studying bispecific antibodies in newly diagnosed diffuse large B-cell lymphoma, how the safety profile of glofitamab plus R-CHOP contributes to its potential for outpatient administration, and where future directions with this research may lead.

AHN Breakthrough

January 3rd 2023

Study Shows Promising Safety, Patient Outcomes Data for MRI-Guided Adaptive Radiation Therapy to Treat Pancreatic Cancer

January 3rd 2023

Findings from a recent prospective study show promising safety and patient outcomes data for locally advanced and borderline resectable pancreatic cancer treatment using ablative Stereotactic MRI-Guided On-table Adaptive Radiation Therapy, also known as SMART.

Toripalimab Plus Chemotherapy BLA Remains Under FDA Review for Recurrent or Metastatic Nasopharyngeal Carcinoma

January 3rd 2023

The FDA has not sent an action letter regarding the biologics license application for toripalimab in combination with chemotherapy as treatment for patients with recurrent or metastatic nasopharyngeal carcinoma.

PDS0101-Based Triplet Produces Prolonged OS in Refractory HPV+ Cancers

January 3rd 2023

Treatment with PDS0101 plus the tumor-targeting IL-12 fusion protein M9241 and bintrafusp alfa elicited encouraging overall survival data in patients with checkpoint inhibitor–naïve and –refractory advanced human papillomavirus–positive anal, cervical, head and neck, vaginal, and vulvar cancer.

Treatment Complexities Continue to Mount in Gynecologic Cancers

January 3rd 2023

Data concerning the long-term benefit of PARP inhibitors as maintenance therapy for select patients with ovarian cancer in later-line settings have come under fire in 2022 as several agents have failed to demonstrate improvements in OS outcomes.

DetermaIO Assay Delineates Single-Agent Immunotherapy Benefit in NSCLC

January 3rd 2023

David L. Saltman MD, PhD, discusses the unique features of the DetermaIO assay, noted the assay’s applications beyond lung cancer, and emphasized that biomarker combinations potentially have greater predictive benefits than single biomarkers.

Waldenström Macroglobulinemia Treatment Moves Away From Chemotherapy

January 2nd 2023

The past decade has been a time of great progress in the research of Waldenström macroglobulinemia and the care of patients with the rare form of non-Hodgkin lymphoma.

Black, Hispanic Women Increasingly Likely to Refuse Surgery for Early Breast Cancer

January 1st 2023

Incidence of surgery refusal has increased by nearly 50% among Black and Hispanic women with potentially curable, nonmetastatic breast cancer over the past decade, according to findings from an analysis of Surveillance, Epidemiology, and End Results Program data.

For Staudt, a Keen Eye Sparks Opportunities to Dig Deeper

December 31st 2022

Driven by his twin passions for music and science, Louis M. Staudt, MD, PhD, has made a career out of reading between the notes.

Neoadjuvant, Adjuvant Pertuzumab/Trastuzumab Regimen Continues to Have Clinical Benefit in Early or Locally Advanced HER2+ Breast Cancer

December 30th 2022

Neoadjuvant and adjuvant pertuzumab plus trastuzumab with docetaxel continued to show improvements in event-free survival, disease-free survival and overall survival vs trastuzumab/docetaxel and placebo in Asian patients with HER2-positive early or locally advanced breast cancer.