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 Raises Questions About BLA for Omburtamab in Pediatric Metastatic Neuroblastoma
October 27th 2022The FDA has expressed concern about the efficacy of 131I-omburtamab prior to a meeting of the regulatory agency’s ODAC to examine data supporting the BLA seeking the agent’s approval for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma.
Trastuzumab Deruxtecan Could Challenge Frontline Trastuzumab/Pertuzumab Combo in HER2+ Breast Cancer
October 27th 2022Sara A. Hurvitz, MD, discusses the evolving treatment paradigm in HER2-positive breast cancer, ongoing research in the space, and developments in the treatment of triple-negative breast cancer.
Fred Hutch Hosts Inaugural Dr E. Donnall Thomas Symposium
October 27th 2022Leading researchers from around the globe visited Fred Hutchinson Cancer Center to honor Dr E. Donnall Thomas and to discuss the future of transplantation, gene, and cellular therapies at the inaugural Dr E. Donnall Thomas Symposium.
Antidrug Antibodies Against Atezolizumab Associated With Poor Outcomes in HCC
October 27th 2022Highly elevated levels of antidrug antibodies against atezolizumab were associated with poorer clinical outcomes for patients who received atezolizumab plus bevacizumab for advanced hepatocellular carcinoma.
Time Required to Address Scientific Questions Generates an Information Dilemma
October 26th 2022One of the more perplexing issues surrounding scientific questions is the extended time required to provide an answer. Even once a well-considered and vetted conclusion is obtained, an additional interval of time may be required to modify or reverse the answer because of new, relevant data.
Melphalan Flufenamide Plus Daratumumab Elicits PFS Benefit in Relapsed/Refractory Myeloma
October 26th 2022The combination of melphalan flufenamide and daratumumab plus hyaluronidase-fihj and dexamethasone improved progression-free survival over daratumumab and dexamethasone alone in select patients with relapsed/refractory multiple myeloma.
Exploration of ADCs Highlights the Drive for Personalized Treatment in Ovarian Cancer
October 26th 2022Rodney Rocconi, MD, discusses the continued exploration of antibody-drug conjugates in patients with ovarian cancer, biomarkers and agents under investigation in the space, and the ongoing research being conducted at the O'Neal Comprehensive Cancer Center.
Camizestrant Improves PFS Vs Fulvestrant in Advanced ER+ Breast Cancer
October 26th 2022Camizestrant led to a statistically significant improvement in progression-free survival compared with fulvestrant in postmenopausal patients with estrogen receptor–positive, locally advanced, or metastatic breast cancer who were previously treated with endocrine therapy for advanced disease.
Early Data Underscore the Potential of Neoadjuvant Immunotherapy in Advanced Resectable CSCC
October 26th 2022Neil D. Gross, MD, FACS, discusses the current deficits in the treatment of patients with cutaneous squamous cell carcinoma in the curative setting and avenues for continued research generated by the primary analysis of the phase 2 trial examining neoadjuvant cemiplimab in this population.
Chemoimmunotherapy Combo Elicits Encouraging Responses in Relapsed High-Risk Neuroblastoma
October 25th 2022The 4-drug combination of irinotecan, temozolomide, dinutuximab, and granulocyte-macrophage colony-stimulating factor elicited objective responses in almost half of patients with high-risk neuroblastoma.
FDA Approves Teclistamab-cqyv for Relapsed or Refractory Multiple Myeloma
October 25th 2022The FDA has granted accelerated approval to teclistamab-cqyv (Tecvayli) for adult patients with relapsed or refractory multiple myeloma who have received at least 4 previous lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Neoadjuvant Therapy and Surgical Advances Continue to Shift Treatment Options for Breast Cancer
October 25th 2022Jeannie Shen, MD, discussed the shifts in surgical practice for patients with breast cancer, the need for a multidisciplinary approach to optimize treatment for individual patients, and ongoing efforts at Huntington Hospital and Cedars-Sinai to increase awareness and improve care for these patients.
Sintilimab Plus Chemotherapy Improves PFS in Pretreated, EGFR-Mutant NSCLC
October 25th 2022Sintilimab plus pemetrexed and cisplatin significantly improved progression-free survival vs pemetrexed and cisplatin alone in patients with advanced, EGFR-mutant non–small cell lung cancer who progressed on prior EGFR TKI therapy.
Cemiplimab Monotherapy Continues to Generate Responses in Locally Advanced or Metastatic CSCC
October 25th 2022Single-agent cemiplimab demonstrated safety and efficacy in patients with locally advanced or metastatic cutaneous squamous cell carcinoma who comprised group 6 of the phase 2 EMPOWER-CSCC-1 trial that was in line with what was previously reported in groups 1, 2, and 3 of the study.
Immunotherapy-Based Endeavors Could Alter Treatment Landscape in Metastatic TNBC
October 24th 2022Yuan Yuan, MD, PhD, discusses the role immune checkpoint inhibitors have played in the treatment of triple-negative breast cancer, ongoing efforts to investigate the role of immunotherapy in breast cancer, and the work Cedars-Sinai is conducting to promote breast cancer awareness.
Real-World Data Could Help Inform Treatment Sequencing Decisions in HR+/HER2- Breast Cancer
October 24th 2022Megan Kruse, MD, discusses the evolving treatment landscape in HR-positive, HER2-negative breast cancer, how the approval of fam-trastuzumab deruxtecan-nxki has affected sequencing choices in HER2-positive disease, and the importance of addressing racial disparities in breast cancer care.
Cediranib Plus Olaparib Elicits rPFS Benefit in Metastatic Castration-Resistant Prostate Cancer
October 24th 2022The combination of cediranib and olaparib significantly improved radiographic progression-free survival compared with olaparib monotherapy in patients with metastatic castration-resistant prostate cancer.
FDA Grants Priority Review to Quizartinib for Newly Diagnosed FLT3-ITD–Positive AML
October 24th 2022The FDA has accepted and granted priority review to the new drug application for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of newly diagnosed adult patients with FLT3-ITD–positive acute myeloid leukemia.
Stark Differences in Mortality Rates Emphasize Ongoing Racial Disparities in Breast Cancer
October 24th 2022Bridget A. Oppong, MD, discussed the importance of recognizing and addressing gaps in outcomes between patients with breast cancer in different racial groups. She also addressed the need for better advocacy for Black patients and advocated for improved screening guidelines to close the gap in racial disparities in breast cancer care.
Xevinapant Plus Chemoradiotherapy Improves OS in Locally Advanced Head and Neck Cancer
October 22nd 2022Xevinapant plus chemoradiotherapy more than halved the risk of death vs placebo plus chemoradiotherapy without increasing toxicity in patients with unresectable, locally advanced head and neck squamous cell carcinoma.