Oncology Today—January 19, 2026

This week’s Oncology roundup covers regulatory approvals and filings, late-stage trial starts, special designations, and market availability across oncology, spanning lung, liver, colorectal, pancreatic, and skin cancers.

In Today’s Newsletter

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🧬 Ivonescimab BLA filed for EGFRm NSCLC combo with chemo [1] [US • 12 Jan 2026]

https://smmttx.com/news/press-releases/news-details/2026/Summit-Therapeutics-Announces-Submission-of-Biologics-License-Application-BLA-to-U-S–FDA-Seeking-Approval-for-Ivonescimab-in-Combination-with-Chemotherapy-in-2L-Treatment-of-Patients-with-EGFRm-NSCLC/default.aspx
Context: Phase 3 HARMONi in EGFR-mutated, non-squamous NSCLC after 3rd-gen EGFR TKI.
Key point: Summit submitted a US BLA in Q4 2025 for ivonescimab plus platinum-doublet chemotherapy in 2L+.
Implication: May influence prescriber choice and payer reviews pending full data.

🛡️ Gotistobart receives FDA orphan drug designation in squamous NSCLC [2] [US • 12 Jan 2026]

https://www.targetedonc.com/view/fda-grants-orphan-drug-designation-for-gotistobart-in-squamous-nsclc
Context: PRESERVE-003 Phase 3 dose-confirmation stage versus docetaxel after PD-(L)1.
Key point: FDA granted ODD to gotistobart, with reported OS improvement and manageable safety.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 First TROP2 NMR biomarker-directed Phase 3 for DATROWAY begins (TROPION-Lung17) [3] [Global • 13 Jan 2026]

https://www.biospace.com/press-releases/tropion-lung17-trop2-biomarker-directed-phase-3-trial-of-datroway-initiated-in-patients-with-previously-treated-advanced-nonsquamous-non-small-cell-lung-cancer
Context: Randomized, open-label DATROWAY 6 mg/kg vs docetaxel in TROP2 NMR-positive nonsquamous NSCLC after IO and platinum.
Key point: ~400 patients, dual primary endpoints PFS and OS, with AI-powered companion diagnostic.
Implication: May influence prescriber choice and payer reviews pending full data.

🌍 ANKTIVA plus checkpoint inhibitor gets Saudi accelerated approval in metastatic NSCLC [4] [Saudi Arabia • 14 Jan 2026]

https://immunitybio.com/saudi-fda-grants-accelerated-approval-to-immunitybios-anktiva-in-combination-with-checkpoint-inhibitors-for-metastatic-non-small-cell-lung-cancer/
Context: SFDA decision references QUILT-3.055 (single-arm) and QUILT-2.023 (randomized) datasets.
Key point: First approval of subcutaneous IL-15 receptor superagonist with CPI in NSCLC after SOC progression.
Implication: May expand screening, initiation, and follow-up at scale.

🧷 Fascin inhibitor NP-G2-044 lands FDA orphan drug designation in pancreatic cancer [5] [US • 12 Jan 2026]

https://www.novita-pharm.com/wp-content/uploads/2026/01/Novita-ODD-Press-Release-1.8.26-vUpload.pdf
Context: Ongoing multicenter Phase 2 across advanced solid tumors, monotherapy and ICI combinations.
Key point: ODD covers pancreatic cancer treatment, including in the setting of checkpoint inhibitor therapy.
Implication: Introduces competition that may affect pricing and formulary access.

🧫 ECT204 (GPC3) CAR T earns FDA RMAT in advanced HCC [6] [US • 12 Jan 2026]

https://www.eurekatherapeutics.com/press-releases/2026/u-s-fda-grants-rmat-designation-to-ect204-an-artemis-car-abtcr-t-cell-therapy-for-advanced-hepatocellular-carcinoma/
Context: RMAT granted based on Phase 1 cohort plus additional ARYA-3 clinical data using ARTEMIS AbTCR architecture.
Key point: RMAT enables enhanced FDA interactions, discussion of surrogate endpoints, and priority review eligibility.
Implication: Signals pipeline investment and modality expansion.

🧱 Braftovi combo gains 1L BRAFV600E mCRC approval in South Korea [7] [South Korea • 09 Jan 2026]

https://www.ono-pharma.com/en/news/20260113.html
Context: BREAKWATER Phase 3, Braftovi plus cetuximab and FOLFOX versus chemotherapy ± bevacizumab.
Key point: Significant ORR and PFS improvements by BICR, safety consistent with known profiles.
Implication: Introduces competition that may affect pricing and formulary access.

🦴 FDA accepts NDA for pimicotinib in TGCT [8] [US • 12 Jan 2026]

https://www.merckgroup.com/en/news/pimicotinib-fda-filing-acceptance-12-01-2026.html
Context: MANEUVER Phase 3 met primary ORR by BICR at week 25, with PRO gains in pain, stiffness, and function.
Key point: FDA accepted NDA for systemic TGCT, supported by primary and longer-term data.
Implication: May influence prescriber choice and payer reviews pending full data.

🧴 UNLOXCYT (cosibelimab-ipdl) now available in the US for aCSCC [9] [US • 15 Jan 2026]

https://www.prnewswire.com/news-releases/sun-pharma-announces-the-availability-of-unloxcyt-cosibelimab-ipdl-for-advanced-cutaneous-squamous-cell-carcinoma-acscc-302662801.html
Context: Updated US label adds long-term pivotal data; PD-L1 with ADCC capability.
Key point: US availability for mCSCC and laCSCC not candidates for curative surgery or radiation.
Implication: Introduces competition that may affect pricing and formulary access.

🤝 Tahoe Therapeutics and Alloy form JV to build first-in-class ADCs [10] [US • 13 Jan 2026]

https://alloytx.com/tahoe-therapeutics-and-alloy-therapeutics-to-form-joint-venture-and-develop-first-in-class-antibody-drug-conjugates-for-hard-to-treat-cancers/
Context: Tahoe’s Mosaic AI platform identified tumor-selective antigens validated across assays and clinical samples.
Key point: JV co-advances two ADC programs using Alloy’s ADC engineering and 82VS company-creation capabilities.
Implication: Signals pipeline investment and modality expansion.

Why it Matters

Precision oncology advances with biomarker-guided ADCs, novel IO backbones, and bispecifics moving through Phase 3 and filings.
Regional regulators, including SFDA and MFDS, are expanding access across IO and targeted therapy, potentially shaping global standards.
RMAT and NDA acceptances show regulators’ openness to new modalities in solid tumors, beyond hematologic indications.
US dermatologic oncology access evolves with aCSCC immunotherapy availability and label updates.

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FAQ

What is ivonescimab’s proposed US indication and basis for filing?

Ivonescimab is a PD-1/VEGF bispecific. Summit filed a BLA for use with chemotherapy in 2L+ EGFR-mutated, non-squamous NSCLC after 3rd-gen EGFR TKI, based on Phase 3 HARMONi results [1]. Endpoints are not detailed here.

Why did gotistobart receive ODD in squamous NSCLC?

ODD followed Phase 3 PRESERVE-003 dose-confirmation data showing an OS signal versus docetaxel in patients previously treated with PD-(L)1 therapy, with manageable safety [2].

What differentiates TROPION-Lung17 for DATROWAY?

It prospectively enrolls by TROP2 NMR using an AI-powered companion diagnostic, randomizing DATROWAY versus docetaxel with dual primary endpoints PFS and OS in post-IO nonsquamous NSCLC [3].

What did the Saudi FDA approve for ImmunityBio?

Accelerated approval of subcutaneous ANKTIVA with a checkpoint inhibitor for metastatic NSCLC after standard therapies, referencing QUILT-3.055 and QUILT-2.023, with a confirmatory study ongoing [4].

What does RMAT status mean for ECT204 in HCC?

RMAT provides intensified FDA guidance, potential for surrogate endpoints, and priority review eligibility, reflecting preliminary clinical evidence from ARYA-3 with the ARTEMIS AbTCR platform [6].

What changed for Braftovi in South Korea?

MFDS approved first-line Braftovi plus cetuximab and FOLFOX for BRAFV600E mCRC after BREAKWATER met ORR and PFS endpoints with consistent safety [7].

Entities/Keywords

Ivonescimab (SMT112/AK112); Summit Therapeutics; EGFR-mutated NSCLC; HARMONi.
Gotistobart (BNT316/ONC-392); BioNTech; OncoC4; squamous NSCLC; PRESERVE-003.
DATROWAY (datopotamab deruxtecan); Daiichi Sankyo; AstraZeneca; TROP2 NMR; TROPION-Lung17.
ANKTIVA (nogapendekin alfa inbakicept); ImmunityBio; Saudi FDA; NSCLC.
NP-G2-044; Novita; fascin inhibitor; pancreatic cancer; ODD.
ECT204; Eureka Therapeutics; ARTEMIS CAR T; GPC3; HCC; RMAT.
Braftovi (encorafenib); cetuximab; FOLFOX; BREAKWATER; mCRC; South Korea MFDS.
Pimicotinib (ABSK021); Merck KGaA; TGCT; MANEUVER; NDA acceptance.
UNLOXCYT (cosibelimab-ipdl); Sun Pharma; aCSCC; US availability.
Tahoe Therapeutics; Alloy Therapeutics; ADC; Mosaic platform; 82VS.