Your go-to digest for the latest breakthroughs in cancer care.
This week’s digest spans across FDA approvals and NCCN guideline updates.Â
Scroll down to read more on this week’s ONCOassist Spotlight Tool !Â
FLAME Trial: 10-Year Focal-Boost Radiotherapy Results in Prostate Cancer
The FLAME Phase III trial confirms that a focal boost (up to 95 Gy) to MRI-visible intraprostatic lesions alongside standard EBRT significantly increases 10-year biochemical disease-free survival (86% vs. 71%) in intermediate- to high-risk localized prostate cancer, without additional toxicity. Other disease-free metrics also favored the boost arm.
(Ref: Menne Guricová, K.et al (2025). Focal boost to the intraprostatic tumor in external beam radiotherapy for localized prostate cancer: 10-year outcomes of the FLAME trial. Journal of Clinical Oncology, Advance online publication.)
Modeyso (Dordaviprone): First FDA-Approved Systemic Therapy for H3 K27M-Mutant DMG
The FDA granted accelerated approval to Modeyso (dordaviprone) for both adult and pediatric patients (≥1 year) with recurrent H3 K27M-mutant diffuse midline glioma. This marks the first systemic therapy approved for this aggressive brain tumor subtype. Clinical data show an objective response rate of approximately 22%, with a median duration of response of ~10.3 months.
(Ref:Jazz Pharmaceuticals. (2025, August 6). FDA grants accelerated approval to dordaviprone (Modeyso) for H3 K27M-mutant diffuse midline glioma [Press release].)
Enhertu (T-DXd) Approved for HER2-Low and HER2-Ultralow Metastatic Breast Cancer
The FDA expanded approval of fam-trastuzumab deruxtecan-nxki (Enhertu) for hormone receptor–positive metastatic breast cancer expressing HER2-low (IHC 1+/2+, ISH−) or HER2-ultralow (IHC 0 with minimal staining), post-endocrine therapy. This extends targeted ADC treatment to previously underserved patient subsets.
(Ref: U.S. Food and Drug Administration. (2025, January 27). FDA approves fam-trastuzumab deruxtecan-nxki for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer [Press release].)
NCCN Guidelines Now Include LEMS Evaluation in SCLC Care Pathways
The updated NCCN Clinical Practice Guidelines for Small Cell Lung Cancer now recommend evaluation for Lambert-Eaton Myasthenic Syndrome (LEMS), including neurologic consultation, PQ- and N-type VGCC antibody testing, and consideration of amifampridine for symptomatic management.
(Ref: Catalyst Pharmaceuticals. (2025, August 6). LEMS antibody testing and treatment recommendations added to NCCN guidelines for SCLC [Press release].)
Bacterial Decolonization with Mupirocin Ointment Reduces Severe AROM in NPC Radiotherapy
A Phase III randomized clinical trial in nasopharyngeal carcinoma patients undergoing definitive chemoradiotherapy compared a bacterial decolonization (BD) protocol using mupirocin nasal ointment with standard of care (SoC). The BD regimen significantly halved the rate of severe (grade ≥3) acute radiation oral mucositis (AROM)—from 47.7% to 22.7% (relative risk 0.48; P < .001). Secondary benefits included reduced oral pain, eased swallowing difficulty, and lower rates of nasal and oral Staphylococcus aureus colonization. Results suggest that mupirocin decolonization is a promising, cost-effective approach for alleviating AROM in nasopharyngeal cancer patients undergoing radiotherapy
(Ref: Liao, Z., Xiong, X., Zhao, L., et al. (2025). Bacterial decolonization with mupirocin ointment for acute radiation oral mucositis prevention: A Phase III randomized clinical trial. JAMA Oncology. Advance online publication.)
ONCOassist Tool Spotlight: Metastatic Castrate Resistant Prostate Cancer Tool
Systemic treatment options for mCRPC include:
- AR pathway inhibitors (ARPi)
- Cytotoxic chemotherapy
- Radioligand therapy
- PARP inhibitors and others.
This tool is designed to show efficacy outcomes with novel treatment options in recent clinical trials for mCRPC patient.
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