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.
Treatment Options Continue to Increase in Low-Risk MDS
November 3rd 2021Azanucleosides, such as azacitidine, remain the backbone of disease-modifying therapy for patients with myelodysplastic syndromes, however, new adjuncts are leading to longer remissions and disease-free survival in patients with low-risk disease.
Testing for Prognostic Markers Is a Necessity for Optimized CLL Care
November 3rd 2021The identification of prognostic markers at diagnosis in chronic lymphocytic leukemia is critical, says Deborah M. Stephens, DO, who explains that the results of testing for these markers can be used to educate patients on their prognosis, tailor therapy accordingly, and enroll eligible patients on clinical trials.
MRD Continues to Show Prognostic Potential in AML and Shape Treatment Decisions
November 3rd 2021Newer modalities are exploring ways to provide more specificity on the value of minimal residual disease negativity in acute myeloid leukemia, since currently there is little definitive action that can be taken with the marker in clinical practice, according to Naval Daver, MD.
FDA Grants Partial Recognition to Memorial Sloan Kettering’s OncoKB Database
November 3rd 2021The Food and Drug Administration has granted recognition to a partial listing of the Oncology Knowledge Base, a comprehensive precision oncology knowledge databased developed by investigators and physicians at Memorial Sloan Kettering Cancer Center.
Genomically-Guided Radiation Dosing Model Shows Promise in Various Cancer Types
November 3rd 2021Radiation oncologists Jacob Scott, MD, DPhil, and Javier Torres-Roca, MD, discuss the benefits of using GARD in a pooled pan-cancer analysis and why there is a call to action to integrate GARD-based radiotherapy dosing in oncology.
FDA Extends Decision Date for Cilta-Cel BLA in Relapsed/Refractory Multiple Myeloma
November 2nd 2021The FDA has extended the Prescription Drug User Fee Act target date for the biologics license application seeking the approval of the CAR T-cell therapy ciltacabtagene autoleucel for use in adult patients with relapsed and/or refractory multiple myeloma.
Genomic Testing Cooperative Seeks to Increase Accessibility to Genomic Profiling Across Cancers
November 2nd 2021Maher Albitar, MD, discusses the unmet needs with genomic testing that served as the impetus to start GTC, the process of becoming a partner with the organization, and the importance of genomic profiling for all patients with cancer.
Regulatory Discussions Continue Regarding BLA for Vicineum in BCG-Unresponsive NMIBC
November 2nd 2021Sesen Bio met with the FDA to discuss questions related to the Chemistry, Manufacturing, and Controls that were raised in the complete response letter previously issued by the regulatory agency regarding the biologics license application for Vicineum as a potential treatment for patients with Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.
Varying Pathological Features Needed to Determine Prognosis in Myoepithelial Tumors
November 2nd 2021There is significant clinical, pathological, and outcome heterogeneity in myoepithelial tumors and prognoses for these tumors cannot be determined by a single pathological feature, but rather, several patient and tumor characteristics.
A Dynamic Treatment Landscape Emerges for Early-Stage TNBC
November 2nd 2021Standard chemotherapy has historically been the mainstay of treatment for patients with diagnoses of early-stage TNBC, but there remains an unmet need to identify novel therapies that improve outcomes and, equally important, to discern which patients may benefit from a given treatment.
FDA Grants Priority Review to Toripalimab for Nasopharyngeal Carcinoma
November 1st 2021The FDA has accepted for review a biologics license application for the use of toripalimab in combination with gemcitabine and cisplatin in the frontline treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma, and for use as a single agent in the second- or later-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma following platinum-containing chemotherapy.
FDA Approval Sought for Parsaclisib in 3 Types of Relapsed/Refractory Non-Hodgkin Lymphoma
November 1st 2021The FDA has accepted a new drug application for the PI3Kδ inhibitor parsaclisib for use in the treatment of patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma.
Infigratinib Shows Promising Early Activity in FGFR2-Altered Cholangiocarcinoma
November 1st 2021The FGFR inhibitor infigratinib demonstrated promising clinical activity and a manageable safety profile in previously treated patients with locally advanced or metastatic cholangiocarcinoma whose tumors harbor FGFR2 gene fusions or rearrangement.
Larotrectinib Yields Promising Efficacy in NTRK+ Lung Cancer, Is Active Against CNS Metastases
October 30th 2021Jessica J. Lin, MD, discussed the impact of larotrectinib in patients with NTRK fusion–positive lung cancer, and the importance of further understanding mechanism of resistance to targeted therapies.
Cancer Dormancy and Tumor Microenvironment Institute to Take Research Efforts to Greater Heights
October 29th 2021The Cancer Dormancy and Tumor Microenvironment Institute, which has recently been launched at Albert Einstein Cancer Center, will focus on taking the tumor microenvironment research being done at the center to the next level and to develop novel technologies that can better identify dormant cancer as well as prevent and control recurrent disease.
Devimistat Falls Flat in Metastatic Pancreatic Cancer and Relapsed/Refractory AML
October 29th 2021Devimistat, which is being evaluated in combination with modified FOLFIRINOX in the frontline treatment of patients with metastatic adenocarcinoma of the pancreas, failed to meet the primary end point of overall survival in the phase 3 AVENGER 500 trial.
FDA Grants Accelerated Approval to Asciminib for Ph+ CML in Chronic Phase
October 29th 2021The FDA has granted an accelerated approval to asciminib for patients with Philadelphia chromosome (Ph)–positive chronic myeloid leukemia (CML) in chronic phase who have previously been treated with 2 or more TKIs, and for those with Ph-positive CML in chronic phase with a T315I mutation.