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.

Tilsotolimod Demonstrates Encouraging Activity, Safety in Early-Stage Melanoma

May 23rd 2022

The synthetic Toll-like receptor 9 agonist tilsotolimod reduced the sentinel lymph node biopsy positivity rate vs placebo in patients with localized, excised melanoma.

New Research Highlights Racial Disparities in Genomic Profiling

May 23rd 2022

A new study by researchers at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine has found that Black women with metastatic breast cancer were less likely to have tumors with treatable genetic variations than white and Asian women.

FDA Approval Sought for N-803 Plus BCG in BCG-Unresponsive NMIBC Carcinoma in Situ

May 23rd 2022

A biologics license application seeking the approval of N-803 in combination with Bacillus Calmette-Guérin in patients with BCG-unresponsive, non–muscle invasive bladder cancer carcinoma in situ with or without Ta or T1 disease has been submitted to the FDA.

FDA Grants Priority Review to Mirvetuximab Soravtansine for FRα-High, Platinum-Resistant Ovarian Cancer

May 23rd 2022

The FDA has accepted and filed a biologics license application for mirvetuximab soravtansine for the treatment of patients with folate receptor alpha–high, platinum-resistant ovarian cancer who have previously received between 1 and 3 systemic therapies.

Tucatinib Plus Trastuzumab Elicits Positive Results in HER2+ Metastatic CRC

May 23rd 2022

The combination of tucatinib and trastuzumab produced promising response rates in patients with previously treated HER2-positive metastatic colorectal cancer.

Clinical Benefit With Elacestrant Shines Spotlight on SERDs in ER+/HER2- Breast Cancer

May 23rd 2022

A significant improvement in progression-free survival has been reported with the oral selective estrogen receptor degrader elacestrant vs standard of care treatments for patients with estrogen receptor–positive, HER2-negative breast cancer.

Molecular Approaches May Increase Responsiveness to Immunotherapy for Patients With Metastatic Melanoma

May 23rd 2022

The recent development of therapeutics which stimulate immune response to tumor cells has revolutionized the treatment landscape for cutaneous melanoma.

Capivasertib Plus Docetaxel Continues to Demonstrate Improved Overall Survival in mCRPC

May 23rd 2022

Capivasertib plus docetaxel continued to show an improvement in overall survival compared with docetaxel alone in patients with metastatic castration-resistant prostate cancer.

Monk Breaks Down Recent Advances Across the Gynecologic Cancer Paradigm

May 22nd 2022

Bradley J. Monk, MD, FACS, FACOG, discusses the future of ovarian cancer treatment, ongoing and future trials, as well as combination therapies that may benefit patients with ovarian cancer, cervical cancer, and endometrial cancer.

Pembrolizumab/Chemo With or Without Bevacizumab Has Potential as New SOC in Metastatic Cervical Cancer

May 21st 2022

Nicoletta Colombo, MD, PhD, discusses the practice-changing data to emerge from KEYNOTE-826 and the next steps for the pembrolizumab plus chemotherapy with or without bevacizumab regimen in patients with cervical cancer.

FDA Approves Azacitidine for Newly Diagnosed Juvenile Myelomonocytic Leukemia

May 20th 2022

The FDA has approved azacitidine (Vidaza) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia.

FDA Places Partial Clinical Hold on Phase 1 Trial Evaluating FHD-286 in Relapsed/Refractory AML and MDS

May 20th 2022

The FDA has placed a partial clinical hold on a phase 1 trial investigating FHD-286 as a treatment for patients with relapsed and/or refractory acute myeloid leukemia and myelodysplastic syndrome.

European Approval Sought for Adagrasib in Previously Treated KRAS G12C–Mutated NSCLC

May 20th 2022

A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of adagrasib for therapeutic use in previously treated patients with non–small cell lung cancer harboring a KRAS G12C mutation.

Selinexor Combo Approaches EU Approval for Refractory Multiple Myeloma

May 20th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of selinexor in combination with bortezomib and low-dose dexamethasone for use in adult patients with multiple myeloma who have previously received 1 to 3 prior lines of treatment.

Addressing Barriers Contributing to Disparities in CRC Screening in Underserved Populations

May 20th 2022

Denalee O'Malley, PhD, sheds light on racial and ethnic disparities in colorectal cancer screening, and strategies that can be used to address existing barriers in the clinic and beyond.

Combination Immunotherapy Improves Outcomes for Patients with Non-small Cell Lung Cancer

May 20th 2022

The phase 2 clinical trial of a multi-center study known as the COAST clinical trial has demonstrated improved outcomes using immunotherapy combinations for patients with unresectable stage III non–small cell lung cancer.

Innovations in Patient-Reported Outcomes Lead to Better Care

May 20th 2022

For decades in cancer care, the compiling of patient-reported outcomes was limited to simple standardized questionnaires completed with pen and paper.

Orteronel Plus ADT Misses OS End Point in Metastatic Hormone-Sensitive Prostate Cancer

May 20th 2022

The addition of orteronel to androgen deprivation therapy vs bicalutamide improved progression-free survival and prostate-specific antigen response in patients with metastatic hormone-sensitive prostate cancer, but missed the primary end point of overall survival in the phase 2 SWOG-1216 trial.

FDA Grants Orphan Drug Designation to XMT-2056 for Gastric Cancer

May 19th 2022

The FDA has granted an orphan drug designation to XMT-2056 for use as a potential therapeutic option for patients with gastric cancer.

Dabrafenib/Trametinib Combo Produces Strong Response in BRAF V600E–Mutated Glioma

May 19th 2022

Dabrafenib plus trametinib produced clinically meaningful objective responses rates in patients with recurrent or progressive BRAF V600E mutation–positive glioma.