Watch Our Video Summary Capturing Top Oncology News from the Last Two Weeks
From FDA approval of subcutaneous KEYTRUDA QLEX and Lilly’s Inluriyo to Japan’s nod for IBTROZI—this week’s Oncology advancements are robust. We span regulatory milestones, targeted therapies, novel formulations, diagnostics, and more, with high-impact approvals and priority reviews across Oncology, underscoring accelerated global access and expanding treatment precision.
Top Stories Covered in This Video
🧬 Rgenta wins FDA orphan status for RGT-61159 [1] [US • 17 Sep 2025]
Context: Phase 1a/b trial ongoing in relapsed/refractory adenoid cystic carcinoma (ACC) or colorectal cancer.
Key point: Orphan Drug Designation granted to RGT-61159, an oral MYB splicing modulator.
Implication: Introduces competition that may affect pricing and formulary access.
🇯🇵 Nuvation Bio’s IBTROZI approved in Japan [2] [Japan • 19 Sep 2025]
Context: Approval based on Phase 2 TRUST program; Nippon Kayaku will market locally.
Key point: MHLW approved IBTROZI (taletrectinib) for ROS1+ NSCLC, with AmoyDx test as companion diagnostic.
Implication: May influence prescriber choice and payer reviews pending full data.
🇪🇺 EC clears ROMVIMZA for TGCT [3] [EU • 17 Sep 2025]
https://www.deciphera.com/news/deciphera-receives-european-commission-approval-for-romvimza
Context: Supported by Phase 3 MOTION trial in TGCT patients not eligible for surgery.
Key point: First EU approval of vimseltinib for symptomatic TGCT.
Implication: May influence prescriber choice and payer reviews pending full data.
💉 FDA approves subcutaneous KEYTRUDA QLEX [4] [US • 19 Sep 2025]
Context: Pivotal Phase 3 trial showed comparable efficacy and PK to IV pembrolizumab.
Key point: KEYTRUDA QLEX (pembrolizumab + berahyaluronidase alfa) approved for subcutaneous use across most solid tumor indications.
Implication: May expand screening, initiation, and follow-up at scale.
🧠 Servier’s VORANIGO approved in EU [5] [EU • 22 Sep 2025]
Context: Phase 3 INDIGO trial showed PFS benefit vs placebo in Grade 2 IDH-mutant glioma.
Key point: EC approved vorasidenib (VORANIGO), first targeted therapy for Grade 2 glioma with IDH mutations.
Implication: May influence prescriber choice and payer reviews pending full data.
🔬 Enhertu + pertuzumab gains Priority Review [6] [US • 24 Sep 2025]
Context: DESTINY-Breast09 Phase 3 showed 44% risk reduction in progression/death vs THP.
Key point: FDA accepted sBLA, granted Priority Review for Enhertu + pertuzumab in 1L HER2+ metastatic breast cancer.
Implication: May influence prescriber choice and payer reviews pending full data.
💊 Lilly’s Inluriyo approved in US [7] [US • 25 Sep 2025]
Context: Phase 3 EMBER-3 showed 38% risk reduction vs standard endocrine therapy.
Key point: FDA approved imlunestrant (Inluriyo) for ER+, HER2–, ESR1-mutated advanced/metastatic breast cancer.
Implication: May influence prescriber choice and payer reviews pending full data.
🇨🇦 OPDIVO SC reimbursement backed in Quebec [8] [Canada • 23 Sep 2025]
https://www.bms.com/ca/en/media/press-release-listing/2025-09-23-press-release.html
Context: INESSS recommended reimbursement for OPDIVO SC across approved tumor indications.
Key point: Subcutaneous nivolumab formulation endorsed for use in Quebec.
Implication: May expand screening, initiation, and follow-up at scale.
Why it matters
- Regulators on three continents advanced multiple first-in-class therapies, signaling accelerated uptake of precision oncology.
- Subcutaneous formulations of checkpoint inhibitors (Merck’s KEYTRUDA QLEX, BMS’s OPDIVO SC) could change infusion workflows.
- Multiple breast cancer approvals (Enhertu combo, Inluriyo) underscore rapid evolution of HER2+ and ESR1-mutated treatment strategies.
- First EU approvals for TGCT (Deciphera) and Grade 2 IDH-mutant glioma (Servier) broaden options in rare oncology indications.
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FAQ
Q1: What is RGT-61159 and why is it significant?
RGT-61159 (Rgenta Therapeutics) is an oral small molecule that modulates MYB splicing. The FDA granted it Orphan Drug Designation for adenoid cystic carcinoma in Sep 2025 [1].
Q2: Where is IBTROZI (taletrectinib) approved?
IBTROZI (Nuvation Bio) has approvals in the US, China, and Japan for ROS1+ NSCLC. Nippon Kayaku will commercialize in Japan following MHLW’s Sep 2025 approval [2].
Q3: What makes ROMVIMZA notable in Europe?
ROMVIMZA (vimseltinib, Deciphera/Ono) became the first approved systemic therapy for TGCT in the EU on 17 Sep 2025 [3].
Q4: How is KEYTRUDA QLEX different from IV pembrolizumab?
KEYTRUDA QLEX (Merck) is a fixed-dose pembrolizumab + berahyaluronidase alfa for subcutaneous use, approved in Sep 2025 across most solid tumor indications. It allows 1–2 minute administration versus 30 minutes for IV [4].
Q5: What is new about VORANIGO in glioma?
VORANIGO (Servier) is the first EC-approved targeted therapy for Grade 2 IDH-mutant glioma, showing significant PFS benefit in Phase 3 INDIGO [5].
Q6: What is Inluriyo’s role in breast cancer?
Inluriyo (imlunestrant, Eli Lilly) was FDA approved on 25 Sep 2025 for ER+, HER2–, ESR1-mutated metastatic breast cancer, after showing improved PFS vs standard ET in EMBER-3 [7].
Entities / Keywords
- Rgenta Therapeutics; RGT-61159; adenoid cystic carcinoma (ACC); MYB splicing
- Nuvation Bio; IBTROZI; taletrectinib; ROS1+ NSCLC; Nippon Kayaku
- Deciphera; Ono Pharmaceutical; ROMVIMZA; vimseltinib; TGCT
- Merck; KEYTRUDA; KEYTRUDA QLEX; pembrolizumab SC
- Servier; VORANIGO; vorasidenib; IDH-mutant glioma
- AstraZeneca; Daiichi Sankyo; Enhertu; trastuzumab deruxtecan; pertuzumab
- Eli Lilly; Inluriyo; imlunestrant; ESR1 mutation; ER+ HER2– MBC
- Bristol Myers Squibb; OPDIVO; nivolumab SC; INESSS
References
https://www.deciphera.com/news/deciphera-receives-european-commission-approval-for-romvimza
https://www.bms.com/ca/en/media/press-release-listing/2025-09-23-press-release.html