Oncology Today—January 5, 2026

This oncology roundup captures major regulatory approvals, strategic portfolio shifts, and access decisions shaping treatment pathways across cancers.

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In Today’s Newsletter

💉 RYBREVANT FASPRO subcutaneous approval with lazertinib option [1] [US • 17 Dec 2025]

https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-enables-the-simplest-shortest-administration-time-for-a-first-line-combination-regimen-when-combined-with-lazcluze-lazertinib

Context: PALOMA-3 met PK co-primary endpoints; MARIPOSA showed OS benefit vs osimertinib in 1L EGFR ex19del/L858R NSCLC.

Key point: FDA approved subcutaneous amivantamab + hyaluronidase across indications, enabling ~5-minute dosing and lower ARR vs IV, including 1L with lazertinib.

Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Verastem ends RAMP-203, pivots to KRAS G12D program VS-7375 [2] [US • 29 Dec 2025]

https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-provides-update-ramp-203-phase-12-clinical

Context: RAMP-203 evaluated avutometinib ± defactinib with sotorasib in KRAS G12C NSCLC.

Key point: Enrollment halted and trial discontinued to prioritize KRAS G12D inhibitor VS-7375 and RAMP-205 in 1L metastatic pancreatic cancer.

Implication: Signals pipeline investment and modality expansion.

🧪 Enhertu + pertuzumab approved for 1L HER2+ mBC [3] [US • 15 Dec 2025]

https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-approved-in-us-for-1l-her2-metastatic-bc.html

Context: DESTINY-Breast09 reported a significant PFS advantage vs THP.

Key point: FDA approved trastuzumab deruxtecan plus pertuzumab as first new 1L regimen in a decade for HER2+ metastatic breast cancer.

Implication: May influence prescriber choice and payer reviews pending full data.

🏷️ DATROWAY EU validation in 1L TNBC not candidates for IO [4] [EU]

https://www.businesswire.com/news/home/20251217527251/en/DATROWAY-Type-II-Variation-Application-Validated-in-the-EU-as-First-Line-Treatment-for-Patients-with-Metastatic-Triple-Negative-Breast-Cancer-Who-are-Not-Candidates-for-Immunotherapy

Context: TROPION-Breast02 met dual primary endpoints, OS and PFS.

Key point: EMA validated the Type II variation for datopotamab deruxtecan monotherapy, starting CHMP review.

Implication: Introduces competition affecting pricing and formulary access.

🧫 EMA supports Phase 3 VCN-01 design in metastatic PDAC [5] [EU • 29 Dec 2025]

https://therivabio.com/press_releases/theriva-biologics-announces-positive-scientific-advice-from-the-european-medicines-agency-ema-on-the-design-of-a-phase-3-trial-of-vcn-01-in-metastatic-pancreatic-ductal-adenocarcinoma-pdac/

Context: VIRAGE Phase 2b showed directional improvements with VCN-01 + gem/nab-paclitaxel.

Key point: CHMP agreed with a single pivotal randomized OS-primary Phase 3 with adaptive design.

Implication: Could inform practice and payer discussions.

🩹 Envafolimab receives US Orphan Drug Designation for GC/GEJ [6] [US • 23 Dec 2025]

https://www.alphamabonc.com/en/html/news/2747.html

Context: Subcutaneous PD-L1 agent with earlier ODDs.

Key point: FDA granted ODD for gastric and GEJ cancers.

Implication: Introduces competition that may affect pricing and access.

🇨🇳 Savolitinib NDA accepted with priority review in China [7] [China • 30 Dec 2025]

https://www.hutch-med.com/savolitinib-gc-china-nda/

Context: Single-arm Phase 2 trial in MET-amplified GC/GEJ.

Key point: NMPA accepted NDA and granted priority review.

Implication: Regulatory movement may expand earlier access.

🚦 Fast Track for BGB-B2033 in HCC [8] [US • 18 Dec 2025]

https://ir.beonemedicines.com/news/beone-medicines-granted-us-fda-fast-track-designation-for-bgb-b2033-as-treatment-for-hepatocellular-carcinoma/03263dc8-561b-4bb2-aba2-3ee84e09c00e

Context: GPC3×4-1BB bispecific in Phase 1.

Key point: FDA granted Fast Track for post-systemic-therapy HCC.

Implication: Signals pipeline investment and modality expansion.

🍁 CDA backs Opdivo + Yervoy in 1L MSI-H/dMMR mCRC [9] [Canada • 17 Dec 2025]

https://www.newswire.ca/news-releases/bristol-myers-squibb-canada-welcomes-positive-cda-recommendation-for-opdivo-r-plus-yervoy-r-as-first-line-treatment-for-msi-h-dmmr-metastatic-colorectal-cancer-848787620.html

Context: CheckMate-8HW demonstrated strong PFS results.

Key point: CDA issued a positive recommendation; Ontario reimbursed via FAST.

Implication: Expands access at a national and provincial level.

🍁 BC to reimburse fruquintinib for previously treated mCRC [10] [Canada • 16 Dec 2025]

https://www.newswire.ca/news-releases/british-columbia-reimburses-fruzaqlatm-fruquintinib-capsules-for-the-treatment-of-metastatic-colorectal-cancer-mcrc–892332379.html

Context: Supported by FRESCO and FRESCO-2 trials.

Key point: BC will reimburse fruquintinib under defined criteria.

Implication: Introduces new treatment access for mCRC.

🧷 BTD for JSKN003 HER2-targeting ADC in PROC [11] [US • 20 Dec 2025]

https://www.alphamabonc.com/en/html/news/2744.html

Context: Early-phase data presented at ASCO.

Key point: FDA granted Breakthrough Therapy Designation.

Implication: Supports accelerated clinical development.

💊 Rucaparib receives regular approval in BRCAm mCRPC [12] [US • 17 Dec 2025]

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer

Context: Based on TRITON3.

Key point: FDA converted accelerated to full approval.

Implication: Reinforces use post-ARPI in BRCAm mCRPC.

🧲 MRT-2359 + enzalutamide shows early activity in mCRPC [13] [US • 16 Dec 2025]

https://ir.monterosatx.com/news-releases/news-release-details/monte-rosa-therapeutics-announces-compelling-clinical-activity

Context: Interim Phase 1/2 analysis.

Key point: PSA responses in AR-mutant patients.

Implication: Signals future Phase 2 expansion.

🇯🇵 Zynyz + chemo approved for 1L advanced anal cancer in Japan [14] [Japan • 22 Dec 2025]

https://investor.incyte.com/news-releases/news-release-details/incyte-japan-announces-approval-zynyzr-retifanlimab-first-line

Context: POD1UM-303/InterAACT2 data.

Key point: First approved 1L systemic regimen for SCAC in Japan.

Implication: Influences prescriber choice and payer reviews.

🧩 J&J completes Halda Therapeutics acquisition, adds RIPTAC platform [15] [US • 29 Dec 2025]

https://www.investor.jnj.com/investor-news/news-details/2025/Johnson–Johnson-completes-acquisition-of-Halda-Therapeutics-and-its-novel-platform-to-revolutionize-cancer-treatment-and-enable-next-generation-oral-therapies/default.aspx

Context: $3.05B acquisition.

Key point: Adds oral regulated-induced-proximity therapeutic platform.

Implication: Expands J&J pipeline across targeted oncology.

Why it Matters

First-line standards are shifting toward targeted and streamlined regimens.
Regulators across major regions advanced therapies in breast, GI, lung, and gynecologic cancers.
Canadian reimbursement innovations are accelerating access.
Fast Track, BTD, and acquisitions highlight investment in ADCs, bispecifics, and degraders.

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FAQ

What practical change comes with RYBREVANT FASPRO approval?

Subcutaneous dosing enables shorter administration and fewer reactions, including 1L with lazertinib for EGFR ex19del/L858R NSCLC [1].

What is the new 1L option for HER2+ metastatic breast cancer?

Enhertu + pertuzumab, approved based on PFS improvement in DESTINY-Breast09 [3].

Which gastric cancer programs moved forward?

Envafolimab received US ODD [6], and China accepted savolitinib’s NDA with priority review [7].

What changed for rucaparib in prostate cancer?

Converted to regular approval for BRCAm mCRPC post-ARPI, supported by TRITON3 [12].

How is access changing in Canada for colorectal cancer?

Opdivo + Yervoy received positive CDA recommendation with Ontario FAST listing [9], and BC will reimburse fruquintinib [10].

Any notable BD moves?

J&J acquired Halda Therapeutics for $3.05B, adding an oral RIPTAC platform [15].

Entities

RYBREVANT FASPRO (amivantamab + hyaluronidase; J&J), LAZCLUZE (lazertinib; Yuhan/J&J), PALOMA-3, MARIPOSA; Enhertu (trastuzumab deruxtecan; AstraZeneca/Daiichi Sankyo), DESTINY-Breast09; Datopotamab deruxtecan/DATROWAY, TROPION-Breast02; VCN-01 (Theriva), PDAC; Envafolimab KN035 (Alphamab/3DMed/Simcere); Savolitinib (HUTCHMED/AstraZeneca); BGB-B2033 (BeOne); Opdivo + Yervoy (BMS), CheckMate-8HW; Fruquintinib FRUZAQLA (Takeda/HUTCHMED); JSKN003 (Alphamab/CSPC); Rucaparib Rubraca; MRT-2359 (Monte Rosa); Retifanlimab Zynyz (Incyte); Halda Therapeutics, RIPTAC.