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The OncFive: Top Oncology Articles for the Week of 9/1
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This list features a snapshot of key August FDA oncology decisions, efforts to integrate health equity into guideline development, and more.
Welcome to OncLive®’s OncFive! Every week, we will compile the top 5 stories in oncology, ranging from pivotal regulatory decisions to news updates and expert interviews spanning tumor types.
Here’s what you may have missed this week:
OncLive’s August Roundup of Key FDA Approvals in Oncology
The FDA was very busy in August, giving the green light to 7 therapeutic options spanning tumor types. Decision highlights include the accelerated approval of afamitresgene autoleucel (Tecelra) for use in select patients with unresectable or metastatic synovial sarcoma who have previously received chemotherapy, vorasidenib (Voranigo) emerging as the first targeted therapy approved for adult and pediatric patients with grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1/IDH2 mutations following surgery, and more.
Targeted Therapy, Vaccines, and Second-Generation ICIs Seek to Redefine mCRC Treatment
In an exclusive interview with OncLive®, Arvind Dasari, MD, MS, an associate professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, shed light on some of the exciting areas of drug development in metastatic colorectal cancer and highlighted the potential movement of targeted therapies into earlier lines of treatment. “A lot of exciting work is being done and we are eagerly looking to seeing the results [of these ongoing trials] in the near future,” he said.
FDA Awards Fast Track Designation to CB-102 in Relapsed/Refractory AML
The regulatory agency granted fast track status to the allogeneic anti–CLL-1 CAR T-cell therapy, CB-012, for use as a potential therapeutic option in patients with relapsed/refractory acute myeloid leukemia. The product, which is engineered with 5 genome edits that are enabled by the next-generation CRISPR technology platform, is under investigation in this population as part of an ongoing phase 1 AMpLify trial (NCT06128044).
FDA Green Lights Companion Diagnostics for Olaparib Plus Abiraterone Acetate in BRCA+ mCRPC
The FDA cleared FoundationOne® CDx and FoundationOne Liquid CDx as companion diagnostics for olaparib (Lynparza) paired with abiraterone acetate (Zytiga) and prednisone or prednisolone in adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer. The olaparib regimen received approval in May 2023 for this indication. “The approval reinforces the importance of testing for genomic mutations at metastatic diagnosis to help guide treatment decisions,” Mia Levy, MD, PhD, chief medical officer of FoundationMedicine, stated in a news release.
The ASCO Palliative Care Expert Panel, in collaboration with ASCO’s Health Equity and Outcomes Committee, has published recommendations for integrating health equity measures into future guideline updates. Recommendations advocated for partnerships with increased representation from historically marginalized groups and patient and community-based advocates; a reinforcement of implicit bias training for Expert Panel members as a component of guideline preparation; stratified recommendations and/or guidelines for additional groups; and more.
