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.

Asciminib Moves Toward EU Approval for Ph+ CML in Chronic Phase

June 24th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorization for asciminib for the treatment of adult patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase who were previously treated with at least 2 TKIs.

Cilta-cel Elicits an ORR of 100% in Multiple Myeloma After Early Relapse on Initial Therapy

June 24th 2022

The CAR T-cell therapy ciltacabtagene autoleucel generated a high response rate in patients with multiple myeloma who experienced early clinical relapse or failure to initial therapy.

Cobolimab Plus Dostarlimab Achieves Clinical Responses in Advanced Melanoma

June 24th 2022

Treatment with the combination of cobolimab and dostarlimab led to an overall objective response rate and immune-related ORR of 42.9% consisting of all partial responses in patients with advanced or metastatic melanoma.

Iopofosine I-131 Under Further Investigation in CLOVER WaM Trial in Waldenström Macroglobulinemia

June 23rd 2022

Sikander Ailawadhi, MD, discusses early efficacy observed with iopofosine I-131, the rationale of investigating the agent in the CLOVER WaM trial in patients with Waldenström macroglobulinemia, and how the radiotherapeutic could affect the treatment paradigm.

Successful Treatment Options Expand to Earlier Lines in RCC and Urothelial Cancer

June 23rd 2022

Tian Zhang, MD, discusses the benefits of multidisciplinary collaboration, how to select the best agents for each patient, and how treatments such as radiation in RCC and bladder-sparing chemoradiation in urothelial cancer fit into the overall treatment paradigms for these diseases.

CHMP Recommends Melphalan Flufenamide for Triple-Class Refractory Multiple Myeloma

June 23rd 2022

The European Medicines Agency's Committee for Medicinal Products for Human Use has unanimously recommended full marketing authorization approval of melphalan flufenamide for patients with triple-class refractory multiple myeloma.

FDA Approval Sought for Elacestrant in ER+/HER2- Breast Cancer

June 23rd 2022

A new drug application has been submitted to the FDA seeking the approval of elacestrant in the treatment of patients with estrogen receptor–positive, HER2-negative, advanced or metastatic breast cancer.

Crenolanib Plus Chemotherapy Provides Long-Term Survival Benefit in FLT3-Mutant AML

June 23rd 2022

Eunice Wang, MD, discusses the long-term results of a phase 2 trial investigating crenolanib plus chemotherapy in adult patients with newly diagnosed FLT3-mutant acute myeloid leukemia.

HPN328 Elicits Antitumor Activity in Small Cell Lung Cancer and Other NETs

June 23rd 2022

HPN328, a novel half-life extended DLL3-targeting T-cell engager, demonstrated clinical activity and tolerability in patients with pretreated small cell lung cancer and other neuroendocrine tumors, according to findings from a phase 1/2 study (NCT04471727).

Sylvester Announces Transformational Cancer Research Building

June 23rd 2022

Sylvester Comprehensive Cancer Center is making another bold move to accelerate cancer research, celebrating the groundbreaking for a 244,000-square-foot, state-of-the-art Sylvester Comprehensive Cancer Center - Transformational Cancer Research Building.

NCCN Adds Trastuzumab Deruxtecan, Sacituzumab Govitecan to Guidelines for Advanced Breast Cancer

June 23rd 2022

“Compelling” data support the use of trastuzumab deruxtecan in patients with HER2-low metastatic breast cancer and the use of sacituzumab govitecan for patients with triple-negative breast cancer or hormone receptor–positive, HER2-negative disease.

FDA Approves Dabrafenib Plus Trametinib for BRAF V600E–Mutated Unresectable or Metastatic Solid Tumors

June 22nd 2022

The FDA has granted an accelerated approval to dabrafenib plus trametinib for the treatment of adult and pediatric patients aged 6 years and older with unresectable or metastatic solid tumors harboring a BRAF V600E mutation who have progressed following previous treatment and who have no satisfactory alternative treatment options.

FDA Grants Orphan Drug Designation to VBI-1901 for Glioblastoma

June 22nd 2022

The FDA has granted an orphan drug designation to VBI-1901, a novel cancer immunotherapeutic vaccine candidate, as a potential therapeutic option for patients with glioblastoma.

UK’s MHRA Accepts Marketing Authorization Application for Aumolertinib in EGFR+ NSCLC

June 22nd 2022

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency accepted for review the marketing authorization application for aumolertinib for the first-line treatment of adult patients with locally advanced or metastatic non–small cell lung cancer with activating EGFR mutations and locally advanced/metastatic EGFR T790M mutation–positive non–small cell lung cancer.

FDA Grants Orphan Drug Designation to MB-106 for Waldenström Macroglobulinemia

June 22nd 2022

The FDA has granted an orphan drug designation to the CD20-targeted autologous CAR T-cell therapy, MB-106, for use as a potential therapeutic option in patients with Waldenström macroglobulinemia.

New USPSTF Guidelines Increase Lung Cancer Screening Among African Americans

June 22nd 2022

The US Preventive Services Task Force updated its lung cancer screening guidelines in 2021 to include more members of vulnerable populations, including African Americans, women, and the LGBTQ community.

EMA Accepts Type II Application for Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer

June 22nd 2022

The European Medicines Agency has validated a Type II Variation application for trastuzumab deruxtecan as monotherapy for adults with unresectable or metastatic HER2-low breast cancer.

Capmatinib Approved in Europe for METex14-Altered Advanced NSCLC

June 22nd 2022

The European Commission has approved capmatinib as a single agent for the treatment of patients with MET exon14 skipping–altered advanced non–small cell lung cancer who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

AHN Cancer Institute, Illumina to Assess In-House Comprehensive Cancer Genomic Profiling to Enhance Patient Care

June 22nd 2022

Allegheny Health Network Cancer Institute and Illumina, Inc., a global leader in DNA sequencing and array-based technologies, announced a collaboration to evaluate the impact of in-house comprehensive genomic profiling to enhance patient care.

Talquetamab Monotherapy Shows Early Promise in Relapsed/Refractory Multiple Myeloma

June 22nd 2022

Monique Minnema, MD, discusses the rationale of the MonumenTAL-1 trial examining talquetamab in multiple myeloma, the safety and efficacy reported thus far with the bispecific antibody, and next steps for further exploration.