Weekly Oncology Highlights | Oncology News, Updates and Spotlights

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.     

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