Your go-to digest for the latest breakthroughs in cancer care.

This week’s digest spans across FDA approvals and NCCN guideline updates. 

Scroll down to read more on this week’s ONCOassist Spotlight Tool ! 

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.)

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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].)

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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].)

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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].)

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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.)

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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.

Join the ONCOassist oncology community, the go-to CE‑approved app for oncology professionals worldwide !

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• Stay informed with ONCOnews & ONCOvideos featuring expert insights, conference coverage and peer-tested protocols 

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Your go-to digest for the latest breakthroughs in cancer care.

This week’s digest spans EU approvals in myeloma and lung cancer, precision-driven trials in breast and hematologic oncology, and a biomarker breakthrough in lung adenocarcinoma brain metastasis.

Leading voices. Big insights. Scroll down for Dr. Maria Barbu!

Sarclisa (Isatuximab) Gains EU Approval in Transplant-Eligible Newly Diagnosed Multiple Myeloma

On July 25, 2025, the European Commission approved Sarclisa combined with VRd (bortezomib, lenalidomide, dexamethasone) as induction therapy for transplant-eligible NDMM. The GMMG-HD7 Phase III trial showed significant MRD negativity and prolonged progression-free survival versus VRd alone.
Clinical insight: This approval broadens Sarclisa’s role to include early disease lines, regardless of transplant eligibility.
(Ref: Sanofi press release citing GMMG-HD7 results and EC approval, July 25, 2025)

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CHMP Recommends TEVIMBRA (Tislelizumab) for Resectable NSCLC (RATIONALE-315) Trial

On July 28, 2025, CHMP issued a positive opinion for TEVIMBRA plus platinum-based chemo as neoadjuvant therapy followed by adjuvant monotherapy in high-risk resectable NSCLC. In the Phase III RATIONALE‑315 trial, TEVIMBRA significantly improved MPR (56.2% vs 15.0%), pCR (40.7% vs 5.7%), and event-free survival (HR 0.56; P=0.0003).
Practice relevance: Could establish the first perioperative immunotherapy standard in early-stage NSCLC.
(Ref: BeOne Medicines CHMP recommendation release, July 28, 2025)

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TEODOR Trial Launched to Evaluate ct-DNA Guided  De-escalation in HR+ Breast Cancer

Natera and ABCSG have initiated the TEODOR Phase II RCT, investigating whether hormone receptor-positive, HER2-negative patients who are ctDNA-negative and endocrine-responsive can safely skip neoadjuvant chemotherapy in favor of endocrine therapy. Primary endpoints are pCR rate and modified PEPI score.
Innovative approach: Personalizes neoadjuvant decision-making via ctDNA and endocrine sensitivity metrics.
(Ref: Natera press release announcing TEODOR trial launch, July 29, 2025)

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Pirtobrutinib (Jaypirca) Meets Primary Endpoint Against Ibrutinib in First-Line CLL/SLL (BRUIN CLL-314)

On July 29, 2025, Lilly announced that pirtobrutinib demonstrated non-inferiority and statistical superiority, in overall response rate versus ibrutinib in treatment-naïve or BTKi-naïve CLL/SLL, in the head-to-head BRUIN CLL‑314 Phase III trial. PFS data is immature but trending favourably.
Clinical takeaway: This is first head-to-head evidence supporting a non-covalent BTK inhibitor in frontline CLL/SLL.
(Ref: Lilly press release with BRUIN trial topline results, July 29, 2025)

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Neuronatin (NNAT) Overexpression Predicts Brain Metastatis and Poor Survival in Lung Adenocarcinoma

A retrospective study of 200 lung adenocarcinoma patients (33 with brain metastasis) showed that nuclear NNAT immunopositivity corresponded with significantly shorter overall survival (7.6 vs 24.4 months) and independently predicted brain metastasis risk. NNAT-IRS positivity was similarly linked to diminished outcomes.
Translational insight: NNAT may serve as a valuable early prognostic biomarker to stratify high-risk patients for brain-directed surveillance and intervention.
(Ref: Basaran Goksen et al. Scientific Reports 2025;15:27653)

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This week’s Oncology Spotlight: Dr. Maria Barbu on Cancer Care in Romania!

In this week’s special segment from IUCS 2024, we speak with Dr. Maria Barbu, a medical oncologist from Bucharest, Romania. CLICK HERE TO WATCH!Dr. Barbu shares her perspective on the evolving oncology landscape in Eastern Europe, particularly in the treatment of prostate cancer.Explore more stories & insights on ONCOassist. Your clinical edge, just a tap away. 

Join the ONCOassist oncology community, the go-to CE‑approved app for oncology professionals worldwide !

•  Access essential tools like staging systems, toxicity scoring, drug calculators, prognostic scores and NCCN regimens,all in one place .
• Stay informed with ONCOnews & ONCOvideos featuring expert insights, conference coverage and peer-tested protocols 

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Your go-to digest for the latest breakthroughs in cancer care.

This week’s updates spans EU precision approvals in prostate and breast cancer, immunotherapy-driven de-escalation in cSCC, and generic access gains, underscoring strides toward personalized, accessible oncology care.

Leading voices. Big insights. Scroll down to watch now Dr. Vinayak Maka’s Oncology Spotlight!

EU Approves Nubeqa (Darolutamide) for Metastatic Hormone-Sensitive Prostate Cancer 

On July 21, 2025, the European Commission approved Nubeqa™ (darolutamide) plus ADT in mHSPC, based on the Phase III ARANOTE trial showing a 46% reduction in radiographic progression or death (HR 0.54; 95% CI 0.41–0.71; P < 0.0001). The safety profile was consistent with published data, and the indication now supports use with or without chemotherapy.
Clinical insight: Offers flexibility to tailor therapy intensity in mHSPC patients.
(Ref: Bayer press release reporting ARANOTE outcomes and EC approval, July 21, 2025)

Blenrep (Belantamab Mafodotin) Combinations Approved in EU for Relapsed/Refractory Multiple Myeloma

In relapsed/refractory multiple myeloma after ≥ 1 prior therapy (including prior lenalidomide for BPd), the European Commission approved Blenrep + bortezomib + dexamethasone (BVd) and Blenrep + pomalidomide + dexamethasone (BPd) on July 24, 2025. Head-to-head Phase III DREAMM‑7 and DREAMM‑8 trials showed superior progression-free survival, with DREAMM‑7 also demonstrating a ~42% overall survival benefit compared to daratumumab-based triplets. Ocular events were common but manageable; discontinuation rates were ≤ 9%, and non‑ocular AEs included thrombocytopenia, neutropenia, diarrhoea and COVID‑19.
Practice shift: Blenrep becomes the first anti‑BCMA ADC combination approved in the EU, offering substantial PFS/OS gains and outpatient-friendly administration in the earliest relapsed setting, redefining options post–first relapse.
(Ref: GSK press releases and CHMP positive opinion based on DREAMM‑7/8 efficacy and safety data; Reuters on EU approval and global context)

EC Approves Itovebi™ (Inavolisib) for PIK3CA‑Mutated HR‑Positive, HER2‑Negative Advanced Breast Cancer 

On July 23, 2025, the European Commission approved Inavolisib combined with palbociclib and fulvestrant for adults with PIK3CA-mutated, ER-positive, HER2-negative advanced breast cancer relapsing within 12 months post-endocrine therapy. The INAVO120 Phase III data showed 57% PFS improvement (HR 0.43; median 15.0 vs 7.3 months; P < 0.001), 33% OS benefit (HR 0.67; P = 0.019), and delayed chemotherapy initiation by approximately two years.
Impact: First PI3K-targeted therapy delivering both PFS and OS benefit in this biomarker-defined subgroup, underscores upfront genomic testing.
(Ref: Roche and EMA documentation of INAVO120 final OS analysis and EC approval, July 2025)

EC Approves DARZALEX® (Daratumumab SC) for High‑Risk Smouldering Multiple Myeloma

On July 23, 2025, the European Commission authorized subcutaneous daratumumab as first licensed monotherapy for high-risk smouldering multiple myeloma. The Phase III AQUILA study demonstrated a 51% reduction in progression to active MM or death versus observation.
Breakthrough: Establishes the first early-intervention, approved therapeutic for high-risk SMM.
(Ref: CHMP positive opinion and EC approval based on AQUILA outcomes as reported by Janssen in mid‑2025 )

ECUS FDA Tenatatively Approves Zydus Generic Ibrutinib Tablets for CLL/SLL 

On July 24, 2025, Zydus Lifesciences received tenatative U.S. FDA approval for generic Ibrutinib tablets in all three strenghts for CLL/SLL with 17p deletion and Waldenstrom’s macroglobulinemia. Branded Ibrutinib annual U.S. sales are estimated at USD 2.15 billion. Significance: Paves way for broader access and cost reduction in BTK- inhibitor therapy upon patent expiry. (Ref: FDA tenatative approval report and market analysis in targeted oncology news, July 24, 2025)

This week’s Oncology Spotlight: Dr. Vinayak Maka on using the ONCOassist app!

In this podcast, as one of our earliest users in India, Dr. Maka shares how the app transformed the way he accesses staging systems, toxicity grading, oncology calculators, and real-time updates at the point of care.  Explore more stories & insights on ONCOassist. Your clinical edge, just a tap away.     

Join the ONCOassist oncology community, the go-to CE‑approved app for oncology professionals worldwide !

•  Access essential tools like staging systems, toxicity scoring, drug calculators, prognostic scores and NCCN regimens,all in one place .
• Stay informed with ONCOnews & ONCOvideos featuring expert insights, conference coverage and peer-tested protocols 

Download the app here:

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