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 Grants Fast Track Designation to Belzupacap Sarotalocan for Non–Muscle Invasive Bladder Cancer

July 7th 2022

The FDA has granted a fast track designation to belzupacap sarotalocan for the treatment of patients with non–muscle invasive bladder cancer, representing the first virus-like drug conjugate candidate therapy from Aura Biosciences, Inc., the drug developer.

AL102 Monotherapy Demonstrates Early Antitumor Activity in Desmoid Tumors

July 6th 2022

Interim findings from part A of the phase 2/3 RINGSIDE trial indicated that the selective oral gamma-secretase inhibitor, AL102, was found to have favorable tolerability and early antitumor activity in patients with desmoid tumors.

FDA Accepts BLA Resubmission for Toripalimab in Advanced Nasopharyngeal Carcinoma

July 6th 2022

The FDA has accepted for review a biologics license application resubmission for toripalimab both in combination and as monotherapy for patients with advanced recurrent or metastatic nasopharyngeal carcinoma, according to an announcement from drug developer Coherus.

New Findings in Breast Cancer Trials Call for Restructuring of Disease Subtypes

July 6th 2022

Gregory Vidal, MD, PhD, including the evolution of treatment options for HER2-low breast cancer, emerging antibody-drug conjugates in triple-negative disease, and the viability of HER3 as an emerging target in breast cancer

Higher Rates of Nausea, Appetite Loss Reported With Dexamethasone-Sparing Regimens

July 6th 2022

Patient-reported outcomes from the phase 3 SPARED trial showed that despite consistency in global health status, patients experienced worse nausea and appetite loss with dexamethasone-sparing approaches.

Florida Cancer Specialists & Research Institute Expands Access to Cancer Care in Central Florida with Opening of Kissimmee Cancer Center

July 6th 2022

Florida Cancer Specialists & Research Institute, LLC held a ribbon-cutting ceremony on June 16, 2022 to celebrate the opening of a new clinical site in Kissimmee, FL.

FDA Grants Priority Review to Mosunetuzumab for Relapsed/Refractory Follicular Lymphoma

July 6th 2022

The FDA has accepted a biologics license application and granted a priority review designation to mosunetuzumab, a potential first-in-class CD20 and CD3 T-cell engaging bispecific antibody, for the treatment of patients with relapsed/refractory follicular lymphoma following at least 2 prior systemic therapies.

Real-World Data Underscore Importance of NTRK Gene Fusions in Tumor Agnostic Therapies

July 6th 2022

The role of NTRK gene fusions across multiple cancer types have led investigators to confirm the marker in real-world data analyses.

Tisa-cel Adds a Potential New ‘Standard-of-Care’ in Third-Line Treatment of Follicular Lymphoma

July 6th 2022

Stephen J. Schuster, MD, discusses the implications of the FDA approval of tisagenlecleucel on the treatment strategy for relapsed/refractory follicular lymphoma and the next steps for tisa-cel.

A Growing Arsenal of NSCLC Treatments Take Aim at Oncogenic Fusions

July 5th 2022

A panel of experts discuss their perspectives on testing and targeted therapy for actionable mutations in non–small cell lung cancer.

ANCHOR Study Shows Treatment of Precancerous Lesions in Individuals Living With HIV Reduces Anal Cancer Risk by Half

July 5th 2022

Results from a study of individuals living with HIV show treatment of a precancerous condition known high-grade squamous intraepithelial lesions of the anus cuts the risk of developing anal cancer in this population by more than half.

Tislelizumab Plus Nab-Paclitaxel Elicits Responses in High-Risk, Non–Muscle Invasive Bladder Cancer

July 5th 2022

The addition of tislelizumab to nab-paclitaxel demonstrated efficacy and safety in patients with high-risk non–muscle invasive bladder cancer.

Brexucabtagene Autoleucel Has Durable Efficacy in B-ALL, Irrespective of Age and Tumor Burden

July 4th 2022

Bijal Shah, MD, MS, discusses the long-term data from the ZUMA-3 trial of brexucabtagene autoleucel in patients with relapsed/refractory B-cell acute lymphoblastic leukemia and spotlighted additional areas ripe for further exploration.

Enfortumab Vedotin Maintains Long-Term OS Benefit in Advanced Urothelial Carcinoma

July 3rd 2022

Enfortumab vedotin extended overall survival by 3.97 months compared with chemotherapy for patients with locally advanced or metastatic urothelial carcinoma.

Tucatinib Plus Trastuzumab Induces Durable Tumor Response in HER2+ mCRC

July 2nd 2022

Patients with previously treated metastatic HER2-positive colorectal cancer experienced clinically meaningful and durable responses to treatment with tucatinib plus trastuzumab, according to data from the phase 2 MOUNTAINEER trial.

Mirvetuximab Soravtansine Displays Promising Efficacy in Platinum-Resistant Ovarian Cancer

July 2nd 2022

Patients with platinum-resistant ovarian cancer have historically been an underserved population with few effective treatment options.

ALRN-6924 Halts Development in P53-Mutant NSCLC, Advances in P53-Mutant Breast Cancer

July 1st 2022

Drug manufacturer Aileron plans to stop further enrollment into a phase 1b trial (NCT04022876) after the chemoprotective agent ALRN-6924 missed its composite primary end point for patients with advanced p53-mutant non–small cell lung cancer.

KRYSTAL-12 Investigators Seek to Confirm Adagrasib’s Role in KRAS G12C–Mutant NSCLC

July 1st 2022

Efforts to unlock treatment modalities targeting KRAS mutations have ebbed and flowed for patients with non–small cell lung as investigators face resistance, intolerable toxicity profiles, and a lack of available binding pockets to guide treatment development.

FDA Issues Warning for Increased Risk of Death, Serious AEs with Duvelisib in CLL/SLL

July 1st 2022

The FDA has warned that treatment with duvelisib has shown a possible increased risk of death and serious adverse effects compared with ofatumumab in patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma.

FDA Grants Orphan Drug Designation to Evorpacept for AML

July 1st 2022

The FDA has granted an orphan drug designation to evorpacept, a next-generation CD47 blocker, for use as a potential therapeutic option for patients with acute myeloid leukemia.