Oncology Today—November 3, 2025

This week’s oncology news delivers the latest updates, developments, and progress from leading biopharma companies.

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🧠 Cellectar gains FDA Rare Pediatric Disease Designation for iopofosine I-131 [1] [US • 27 Oct 2025]

https://investor.cellectar.com/press-releases/detail/379/cellectar-biosciences-receives-rare-pediatric-disease
Context: Based on interim Phase 1b CLOVER-2 data in pediatric high-grade glioma (n=14).
Key point: Rare Pediatric Disease Designation adds to iopofosine’s prior orphan and breakthrough designations; eligible for Priority Review Voucher upon approval.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 Exousia Pro earns FDA Orphan Drug Designation for GBM exosome therapy [2] [US • 28 Oct 2025]

https://www.otcmarkets.com/stock/MAJI/news/Exousia-Pro-is-Excited-to-Announce-that-it-has-Received-Orphan-Drug-Designation-from-the-FDA?id=497771
Context: Preclinical stage application via subsidiary Exousia AI targeting malignant glioma.
Key point: The ODD supports advancement of exosome-based genetic payload delivery for glioblastoma multiforme.
Implication: Signals pipeline investment and modality expansion.

💉 EC approves Keytruda for perioperative use in PD-L1–positive resectable LA-HNSCC [3] [EU • 29 Oct 2025]

https://www.merck.com/news/european-commission-approves-keytruda-pembrolizumab-as-part-of-a-treatment-regimen-for-adults-with-resectable-locally-advanced-head-and-neck-squamous-cell-carcinoma-la-hnscc-expressing-pd-l1/
Context: Based on Phase 3 KEYNOTE-689 trial (n=714).
Key point: Keytruda regimen reduced event-free survival risk by 30% vs standard adjuvant therapy in PD-L1 CPS ≥1 population.
Implication: May influence prescriber choice and payer reviews pending full data.

☢️ Actinium’s ATNM-400 shows preclinical superiority in EGFR-mutant NSCLC [4] [US • 27 Oct 2025]

https://ir.actiniumpharma.com/press-releases/detail/509/actinium-announces-superior-anti-tumor-activity-of-atnm-400
Context: Presented at AACR-NCI-EORTC meeting.
Key point: ATNM-400 achieved 3–5× tumor inhibition vs osimertinib, Dato-DXd and amivantamab; complete regression in combo with osimertinib.
Implication: May influence prescriber choice and payer reviews pending full data.

🫁 Daiichi Sankyo starts DESTINY-Lung06 Phase 3 trial of Enhertu plus pembrolizumab [5] [JP/US • 30 Oct 2025]

https://www.daiichisankyo.com/files/news/pressrelease/pdf/202510/20251031_E.pdf
Context: Global Phase 3 enrolling ~686 HER2-overexpressing NSCLC patients (PD-L1 TPS <50%).
Key point: First-line combination aims to replace chemotherapy backbone with Enhertu plus immunotherapy.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 GSK’227 granted EMA Orphan Drug Designation for pulmonary NEC (SCLC) [6] [EU • 31 Oct 2025]

https://www.gsk.com/en-gb/media/press-releases/gsk-s-b7-h3-targeted-antibody-drug-conjugate-gsk-227-receives-orphan-drug-designation-in-the-eu/
Context: Supported by Phase 1 ARTEMIS-001 data showing durable responses in ES-SCLC.
Key point: Fourth regulatory designation (includes PRIME and FDA Breakthrough).
Implication: Signals pipeline investment and modality expansion.

🇨🇦 Enhertu approved in Canada for HR-positive HER2-low or ultralow metastatic breast cancer [7] [CA • 29 Oct 2025]

https://www.newswire.ca/news-releases/enhertu-r-approved-in-canada-as-the-first-and-only-her2-directed-therapy-for-patients-with-hr-positive-her2-low-or-her2-ultralow-metastatic-breast-cancer-following-disease-progression-after-one-or-more-endocrine-therapies-838533131.html
Context: Based on Phase 3 DESTINY-Breast06 trial.
Key point: Enhertu reduced risk of progression or death by 36% vs chemotherapy (HR 0.64).
Implication: May influence prescriber choice and payer reviews pending full data.

🔬 Revolution Medicines’ daraxonrasib receives FDA Orphan Drug Designation for pancreatic cancer [8] [US • 27 Oct 2025]

https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-rason-multi-selective-inhibitor
Context: RAS(ON) multi-selective inhibitor in global Phase 3 RASolute-302 trial for second-line PDAC.
Key point: Targets multiple RAS mutations (G12X, G13X, Q61X) found in >90% of pancreatic cancers.
Implication: Signals pipeline investment and modality expansion.

🧪 Dewpoint’s condensate modulator DPTX3186 granted FDA Orphan Drug Designation in gastric cancer [9] [US • 29 Oct 2025]

https://dewpointx.com/fda-grants-orphan-drug-designation-to-dewpoint-therapeutics-dptx3186-for-the-treatment-of-gastric-cancer/
Context: First orphan designation for a condensate-modulating therapeutic.
Key point: Oral small-molecule targeting Wnt/β-catenin signaling; IND recently cleared.
Implication: Signals pipeline investment and modality expansion.

💠 Canada’s Drug Agency recommends reimbursement for Elahere in platinum-resistant ovarian cancer [10] [CA • 30 Oct 2025]

https://www.cantechletter.com/newswires/elahere-receives-positive-reimbursement-recommendation-by-canadas-drug-agency-for-certain-types-of-platinum-resistant-ovarian-cancers/
Context: CDA-AMC’s Target Zero review enabled pre-approval submission.
Key point: Elahere (mirvetuximab soravtansine) recommended for FRα-positive, platinum-resistant ovarian, fallopian tube or peritoneal cancers after 1–3 prior regimens.
Implication: May expand screening, initiation, and follow-up at scale.

Why It Matters

Pediatric, rare-disease, and oncology designations highlight continued regulatory momentum across radiotherapies, ADCs and targeted inhibitors.
Combination immunotherapy and radiotherapeutic strategies gain traction in lung and head-and-neck cancers.
Canada accelerates oncology access via CDA-AMC Target Zero model.
Condensate-biology and exosome-based modalities emerge as new rare-cancer platforms.
Cross-regional (US-EU-Canada-Japan) designations underscore harmonized incentives for orphan and targeted cancer programs.

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FAQ

What is iopofosine I-131 and what does Cellectar’s designation mean?

Iopofosine I-131 is a phospholipid ether radioconjugate targeting pediatric high-grade glioma. FDA’s Rare Pediatric Disease Designation may qualify Cellectar [1] for a Priority Review Voucher if approved.

How does Exousia Pro’s exosome therapy work?

Exousia’s approach uses engineered exosomes to deliver nucleic acids into glioblastoma cells, enabling targeted modulation of tumor biology [2].

What distinguishes Keytruda’s new EU approval?

The EC approved Keytruda [3] for perioperative use (neoadjuvant + adjuvant) in PD-L1–positive resectable LA-HNSCC based on KEYNOTE-689.

What is ATNM-400 and how did it perform preclinically?

ATNM-400 [4] is an Actinium-225 antibody radioconjugate showing 3–5× tumor inhibition vs EGFR TKIs and ADCs in NSCLC, with synergy when combined with osimertinib.

What is the significance of Enhertu’s dual updates in lung and breast cancer?

Daiichi Sankyo and AstraZeneca advanced Enhertu [5][7] into first-line NSCLC Phase 3 (DESTINY-Lung06) and gained Health Canada approval in HER2-low/ultralow breast cancer, broadening HER2-targeted reach.

How do new orphan designations for GSK, Revolution, and Dewpoint affect competition?

These ODDs [6][8][9] offer seven-year exclusivity in the US or market incentives in the EU, supporting pipeline diversification in SCLC, pancreatic, and gastric cancers.

What does Canada’s Elahere reimbursement mean for patients?

CDA-AMC’s recommendation [10] may speed public coverage for FRα-positive platinum-resistant ovarian cancers under the new Target Zero pathway.

Entities / Keywords

Cellectar Biosciences; Exousia Pro; Merck; Actinium Pharmaceuticals; Daiichi Sankyo; AstraZeneca; GSK; Revolution Medicines; Dewpoint Therapeutics; AbbVie; iopofosine I-131; daraxonrasib; DPTX3186; Enhertu (trastuzumab deruxtecan); Elahere (mirvetuximab soravtansine); Keytruda (pembrolizumab); ATNM-400; GSK’227; Orphan Drug Designation; Rare Pediatric Disease; HER2-low breast cancer; HER2-overexpressing NSCLC; platinum-resistant ovarian cancer.