Oncology Weekly News - September 29th 2025

Oncology Update: Vorasidenib Approval, Plixorafenib Efficacy, OPDIVO Reimbursement & More

From the EU approval of vorasidenib as the first targeted therapy for Grade 2 IDH-mutant glioma to positive interim results in BRAF V600 CNS tumors with plixorafenib, this roundup highlights advancing cancer therapies. It includes UK authorization of cabozantinib for neuroendocrine tumors, FDA priority review of Enhertu plus pertuzumab, and breakthrough data supporting new drug developments and reimbursement decisions across breast, pancreatic, colorectal, and prostate cancers, as well as immunotherapy innovations.

In Today’s Newsletter

🧠 EU clears Voranigo as first targeted therapy in Grade 2 IDH-mutant glioma [1] [EU • 22 Sep 2025]

https://www.prnewswire.com/news-releases/european-commission-approves-serviers-voranigo-vorasidenib-as-the-first-targeted-therapy-for-grade-2-idh-mutant-glioma-in-the-eu-302562180.html
Context: EC approval based on INDIGO Phase 3 trial (n≈331) showing significant PFS and TTNI benefit.
Key point: Servier’s vorasidenib approved for post-surgical Grade 2 IDH1/2-mutant glioma patients not requiring immediate RT/CT.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Fore Bio plixorafenib passes interim efficacy in BRAF V600 CNS basket [2] [24 Sep 2025]

https://fore.bio/fore-biotherapeutics-announces-positive-outcome-from-a-planned-interim-efficacy-analysis-for-the-forte-basket-study-evaluating-plixorafenib-as-a-monotherapy-for-recurrent-or-progressive-braf-v600-prim/
Context: Phase 2 FORTE basket; IDMC reviewed first 25 patients with recurrent/progressive BRAF V600 CNS tumors.
Key point: Interim efficacy threshold met; study continues toward registrational topline in 2H26.
Implication: May influence prescriber choice and payer reviews pending full data.

💊 UK authorises cabozantinib in advanced neuroendocrine tumors [3] [UK • 22 Sep 2025]

https://www.ipsen.com/uk-ireland/u-k-mhra-grants-marketing-authorisation-for-cabozantinib-ipsen-a-first-for-previously-treated-advanced-neuroendocrine-tumours/
Context: MHRA approval based on CABINET Phase 3 showing significant PFS benefit in pNETs and epNETs.
Key point: First systemic therapy approved in UK for previously treated advanced NETs beyond SSAs.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Enhertu + pertuzumab earns US FDA Priority Review in 1L HER2+ mBC [4] [US • 24 Sep 2025]

https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-plus-pertuzumab-granted-priority-review-us-1st-line-treatment-patients-with-her2-positive-metastatic-breast-cancer.html
Context: DESTINY-Breast09 Phase 3; Enhertu+pertuzumab reduced risk of progression/death by 44% vs THP.
Key point: FDA Priority Review granted; PDUFA in 1Q26.
Implication: May influence prescriber choice and payer reviews pending full data.

💊 Lilly wins US approval for Inluriyo in ESR1-mutant breast cancer [5] [US • 25 Sep 2025]

https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-inluriyo-imlunestrant-adults-er-her2-esr1
Context: EMBER-3 Phase 3; oral imlunestrant cut progression/death risk by 38% vs endocrine therapy.
Key point: FDA approved Inluriyo for ER+, HER2–, ESR1-mutated metastatic breast cancer post ET.
Implication: May influence prescriber choice and payer reviews pending full data.

📊 Roche giredestrant combo improved PFS in Phase 3 evERA trial [6] [CH • 22 Sep 2025]

https://www.roche.com/media/releases/med-cor-2025-09-22
Context: evERA tested giredestrant+everolimus vs SOC endocrine+everolimus post CDK4/6 inhibitor.
Key point: Met both co-primary endpoints in ITT and ESR1-mutated populations; OS trend positive.
Implication: May influence prescriber choice and payer reviews pending full data.

🧩 Alligator’s mitazalimab shows durable survival in pancreatic cancer [7] [SE • 22 Sep 2025]

https://alligatorbioscience.se/en/mfn_news/alligator-announces-final-30-month-optimize-1-results-highlighting-the-potential-of-mitazalimab-in-metastatic-pancreatic-cancer/
Context: OPTIMIZE-1 final 30-month readout; mitazalimab+mFOLFIRINOX in untreated metastatic disease.
Key point: Median OS 14.9m; 21% alive at 30m, favorable vs historical benchmarks.
Implication: May influence prescriber choice and payer reviews pending full data.

⚡ FDA Fast Track for Artios alnodesertib in ATM-negative mCRC [8] [US • 24 Sep 2025]

https://www.globenewswire.com/news-release/2025/09/24/3155260/0/en/Artios-Receives-U-S-FDA-Fast-Track-Designation-for-alnodesertib-in-ATM-negative-Metastatic-Colorectal-Cancer-mCRC.html
Context: Fast Track for alnodesertib+low-dose irinotecan in 3L ATM-negative mCRC.
Key point: Based on early Phase 1/2 STELLA data showing activity across multiple tumor types.
Implication: May influence prescriber choice and payer reviews pending full data.

🔬 FibroGen starts Phase 2 trial of FG-3246 in prostate cancer [9] [US • 24 Sep 2025]

https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-initiates-phase-2-monotherapy-trial-fg-3246-first-class
Context: ADC targeting CD46 in mCRPC; 75-patient dose optimization study.
Key point: Trial includes FG-3180 PET tracer sub-study; interim data expected 2H26.
Implication: May influence prescriber choice and payer reviews pending full data.

💉 OPDIVO SC receives positive reimbursement recommendation in Quebec [10] [CA • 23 Sep 2025]

https://www.bms.com/ca/en/media/press-release-listing/2025-09-23-press-release.html
Context: INESSS backed nivolumab SC across all tumor indications where IV is reimbursed.
Key point: Health Canada approved in May 2025; SC route offers faster administration.
Implication: May expand screening, initiation, and follow-up at scale.

Why it matters

- Regulatory wins (Servier, Ipsen, Lilly, BMS) highlight global diversification of oncology approvals.
- First-in-class targeted agents (vorasidenib, imlunestrant, alnodesertib, FG-3246) show precision oncology momentum.
- Data-rich breast cancer updates (AstraZeneca, Lilly, Roche) reinforce competitive dynamics in ER+ and HER2+ subtypes.
- Alligator’s pancreatic cancer survival outcomes underscore potential for immunotherapy-chemotherapy combos.
- Subcutaneous OPDIVO aligns oncology access with healthcare system efficiency.

📢 Stay Ahead in Oncology Research!

✅ Contact LucidQuest at info@lqventures.com for strategic guidance on oncology innovations and clinical research.

FAQ

What is Voranigo (vorasidenib) and why is the EU approval notable?

Voranigo (Servier) is the first targeted therapy for Grade 2 IDH-mutant glioma approved in the EU, supported by Phase 3 INDIGO trial results showing prolonged progression-free survival (PFS) and delayed need for further therapy [1].

How does plixorafenib differ from earlier BRAF inhibitors?

Plixorafenib (Fore Bio) is described as a “paradox breaker” with lower risks of resistance and side effects compared with earlier BRAF inhibitors, advancing in the FORTE CNS basket study [2].

What did Ipsen’s cabozantinib approval in the UK cover?

Cabozantinib is now authorised for previously treated, unresectable or metastatic pancreatic and extra-pancreatic neuroendocrine tumors (NETs), marking the first systemic therapy option in this UK setting [3].

What distinguishes Lilly’s Inluriyo from Roche’s giredestrant?

Both are oral estrogen receptor-targeting therapies. Inluriyo (imlunestrant; Lilly) is FDA-approved for ESR1-mutant metastatic breast cancer, while giredestrant (Roche) is still investigational, showing PFS benefit in the evERA trial [5][6].

What is the significance of OPDIVO SC’s reimbursement recommendation in Quebec?

INESSS endorsement supports adoption of nivolumab’s subcutaneous form across tumor types, offering shorter administration time and potentially easing healthcare system pressures [10].

Entities / Keywords

Servier; Voranigo; vorasidenib; IDH1; IDH2; glioma; Fore Biotherapeutics; plixorafenib; BRAF V600; FORTE; Ipsen; cabozantinib; Cabozantinib Ipsen; CABINET trial; neuroendocrine tumors; AstraZeneca; Daiichi Sankyo; Enhertu; trastuzumab deruxtecan; pertuzumab; DESTINY-Breast09; Eli Lilly; Inluriyo; imlunestrant; EMBER-3; ESR1 mutation; Roche; giredestrant; evERA; SERD; everolimus; Alligator Bioscience; mitazalimab; OPTIMIZE-1; pancreatic cancer; Artios; alnodesertib; ATR inhibitor; STELLA trial; ATM-negative mCRC; FibroGen; FG-3246; FOR46; CD46 ADC; FG-3180; Bristol Myers Squibb; OPDIVO; nivolumab SC; INESSS; Quebec.