Oncology Today—February 9, 2026

LucidQuest

13 hours ago

This week’s Oncology update , covers regulatory actions, late-stage clinical milestones, access decisions, and expedited designations across solid tumors. Themes include first-line standards evolving, perioperative immunotherapy advances, and broader provincial and national reimbursement moves.

In Today’s Newsletter

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🧬 Kisqali draft reimbursement for high-risk early breast cancer in Canada [1] [Canada • 06 Feb 2026]

https://www.newswire.ca/news-releases/kisqali-r-receives-positive-draft-recommendation-from-canada-s-drug-agency-for-all-eligible-early-breast-cancer-patients-at-high-risk-of-recurrence-887512966.html
Context: Health Canada approved adjuvant ribociclib in Jun 2025; company cites NATALEE for recurrence-risk reduction and safety profile.
Key point: Draft recommendation supports public reimbursement of ribociclib tablets + aromatase inhibitor for stage II–III HR+/HER2- early breast cancer at high risk of recurrence (endpoint not specified here).
Implication: May influence prescriber choice and payer reviews pending full data.

🔬 Zovegalisib granted FDA Breakthrough Therapy in PIK3CA-mutant HR+/HER2- ABC [2] [US • 03 Feb 2026]

https://ir.relaytx.com/news-releases/news-release-details/relay-therapeutics-announces-zovegalisib-granted-breakthrough
Context: Dose 400 mg BID fed selected for Phase 3 ReDiscover-2; initial data presentation planned Mar 16 (ESMO TAT).
Key point: BTD for zovegalisib + fulvestrant after progression on CDK4/6 inhibitor, supported by Phase 1/2 ReDiscover data across kinase and non-kinase PIK3CA mutations.
Implication: Signals pipeline investment and modality expansion.

🎯 Datroway gets US Priority Review for 1L metastatic TNBC (non-IO candidates) [3] [US • 03 Feb 2026]

https://www.astrazeneca.com/media-centre/press-releases/2026/datroway-granted-priority-review-in-the-us-as-1st-line-treatment-for-patients.html
Context: Based on TROPION-Breast02 showing OS and PFS advantages vs chemotherapy; Project Orbis participation.
Key point: FDA accepts and grants Priority Review to datopotamab deruxtecan sBLA for unresectable/metastatic TNBC patients not candidates for PD-1/PD-L1 therapy; PDUFA anticipated Q2 2026.
Implication: May influence prescriber choice and payer reviews pending full data.

🏥Imfinzi + FLOT recommended in EU for perioperative early gastric/GEJ cancer [4] [EU • 02 Feb 2026]

https://www.astrazeneca.com/media-centre/press-releases/2026/imfinzi-recommended-in-eu-for-early-gastric-cancer.html
Context: First immunotherapy-based perioperative regimen in this EU setting if approved; safety consistent with known profiles.
Key point: CHMP positive opinion for durvalumab + FLOT pre-op and post-op, then durvalumab monotherapy, based on MATTERHORN EFS and OS benefits.
Implication: May influence prescriber choice and payer reviews pending full data.

💉Opdivo + Yervoy reimbursed in Ontario FAST program for 1L advanced HCC [5] [Canada • 03 Feb 2026]

Context: Coverage criteria include unresectable disease, Child-Pugh A, good performance status; prior systemic therapy not eligible.
Key point: Ontario becomes first Canadian province to publicly reimburse nivolumab + ipilimumab for unresectable or advanced HCC via FAST accelerated funding pathway.
Implication: May expand screening, initiation, and follow-up at scale.

🧪FDA accepts NDA for zanzalintinib + atezolizumab in previously treated mCRC [6] [US • 02 Feb 2026]

https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-us-fda-accepted-new-drug-application
Context: Dual primary endpoints include OS in ITT and in patients without active liver metastases; final analysis pending mid-2026 per source.
Key point: Standard review with PDUFA 03 Dec 2026; STELLAR-303 showed OS improvement vs regorafenib in intention-to-treat population.
Implication: May influence prescriber choice and payer reviews pending full data.

🧔‍♂️Nubeqa approved in China for mHSPC + ADT with or without chemotherapy [7] [China • 03 Feb 2026]

https://www.bayer.com/media/en-us/nubeqa-darolutamide-receives-third-approval-in-china-for-men-with-advanced-prostate-cancer/
Context: Builds on prior mHSPC with docetaxel and nmCRPC approvals; expands physician flexibility.
Key point: NMPA approves darolutamide + ADT in mHSPC irrespective of docetaxel use, based on ARANOTE rPFS benefit and tolerability.
Implication: Introduces competition that may affect pricing and formulary access.

🧫Quebec reimburses Jemperli + chemotherapy for primary advanced or first recurrent EC [8]

https://ca.gsk.com/en-ca/media/press-releases/quebec-first-province-to-publicly-reimburse-jemperli-dostarlimab-for-injection-plus-chemotherapy-via-ramq-for-the-treatment-of-all-adult-patients-with-primary-advanced-or-first-recurrent-endometrial-cancer/
Context: Based on RUBY Part 1 meeting dual primary endpoints of PFS and OS; pCPA LOI completed Dec 2025.
Key point: RAMQ lists dostarlimab + carboplatin/paclitaxel for all eligible adults with primary advanced or first recurrent endometrial cancer.
Implication: May expand screening, initiation, and follow-up at scale.

🧬Ivonescimab receives 5th NMPA Breakthrough Therapy Designation, now 1L BTC [9] [China • 06 Feb 2026]

https://www.akesobio.com/en/media/akeso-news/260226/
Context: Phase 3 HARMONi-GI1 vs durvalumab + chemotherapy ongoing; Phase 1b/2 signals ORR 63.6% and mOS 16.8 months (per source).
Key point: BTD for PD-1/VEGF bispecific ivonescimab + chemotherapy in first-line advanced biliary tract cancer.
Implication: Signals pipeline investment and modality expansion.

⚡PRN commentary on expedited oncology pathways and select companies [10] [US • 05 Feb 2026]

https://www.prnewswire.com/news-releases/207b-market-shift-the-race-for-fast-track-approval-in-oncology-302680332.html
Context: Includes selected program claims and market size projections; issued on behalf of a company.
Key point: Vendor commentary highlights 2025–2026 surge in oncology approvals and expedited designations, naming Oncolytics, Relay, MAIA, Zai Lab, Arrivent.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

Why it Matters

Regulatory momentum spans breast, gastric/GEJ, colorectal, prostate, biliary tract, and endometrial cancers.
Canadian access moves, including FAST and RAMQ listings, show accelerated provincial uptake for IO and targeted regimens.
US and China expedited pathways prioritize high-need subpopulations and first-line settings.
ADCs and selective pathway inhibitors remain central across 1L and post-CDK4/6 landscapes.

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FAQ

What did Canada’s Drug Agency recommend for ribociclib?

A positive draft recommendation for reimbursement of Kisqali + aromatase inhibitor in stage II–III HR+/HER2- early breast cancer at high risk of recurrence, pending finalization [1].

Which breast-cancer population is covered by zovegalisib’s BTD?

Adults with PIK3CA-mutant HR+/HER2- locally advanced or metastatic disease after progression on a CDK4/6 inhibitor, for use with fulvestrant [2].

What is Datroway’s US filing focused on?

First-line metastatic TNBC patients not eligible for PD-1/PD-L1 therapy, under Priority Review based on TROPION-Breast02 results vs chemotherapy [3].

What perioperative regimen did CHMP back in gastric/GEJ cancer?

Imfinzi + FLOT before and after surgery, then Imfinzi monotherapy, with EFS and OS benefits in MATTERHORN [4].

What did Ontario decide on Opdivo + Yervoy?

Public reimbursement as 1L therapy for unresectable or advanced HCC via the FAST accelerated funding program, with specified eligibility criteria [5].

What indication is in Exelixis’s NDA for zanzalintinib?

Zanzalintinib + atezolizumab in previously treated metastatic colorectal cancer; standard review with PDUFA 03 Dec 2026 [6].

What changed for darolutamide in China?

NMPA approved Nubeqa + ADT for mHSPC with or without chemotherapy, extending use beyond prior regimens, supported by ARANOTE [7].

Who now reimburses Jemperli + chemo in Canada?

Quebec, via RAMQ, for all adult patients with primary advanced or first recurrent endometrial cancer who are candidates for systemic therapy [8].

What’s new for ivonescimab in China?

A fifth Breakthrough Therapy Designation, now for first-line advanced biliary tract cancer in combination with chemotherapy, with a registrational Phase 3 underway [9].

Entities/Keywords

Kisqali, ribociclib; Novartis Canada. Zovegalisib, RLY-2608; Relay Therapeutics; PIK3CA-mutant HR+/HER2- breast cancer. Datroway, datopotamab deruxtecan; AstraZeneca; Daiichi Sankyo; TNBC. Imfinzi, durvalumab; FLOT; gastric; GEJ; CHMP. Opdivo, nivolumab; Yervoy, ipilimumab; Ontario FAST; HCC. Zanzalintinib; atezolizumab; Exelixis; mCRC; STELLAR-303. Nubeqa, darolutamide; Bayer; mHSPC; ARANOTE. Jemperli, dostarlimab; GSK; RAMQ; endometrial cancer. Ivonescimab, AK112; Akeso; biliary tract cancer. Expedited pathways; Breakthrough Therapy; Priority Review; Project Orbis.