Oncology Today—March 23, 2026

This week’s Oncology update highlights EU regulatory expansion, late-stage trial progress, imaging pipeline movement, and continued innovation in ADCs, bispecifics, and targeted therapies across solid tumors.

In Today’s Newsletter

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🧠 Imfinzi approved in EU for early gastric cancer [1] [EU • 16 Mar 2026]

https://www.astrazeneca.com/media-centre/press-releases/2026/imfinzi-approved-in-eu-for-early-gastric-cancer.html
Context: Imfinzi plus FLOT chemotherapy was approved for resectable Stage II–IVA gastric and GEJ cancers in the EU.
Key point: MATTERHORN showed a 29% reduction in progression/recurrence/death and a 22% reduction in mortality versus chemotherapy alone.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 NovaBridge advances givastomig toward accelerated pathway [2] [US • 16 Mar 2026]

https://www.novabridge.com/news-releases/news-release-details/novabridge-announces-productive-fda-type-b-meeting-potential
Context: Givastomig is a CLDN18.2 × 4-1BB bispecific antibody for first-line HER2-negative gastric cancer.
Key point: FDA supported a potential accelerated approval pathway using ORR, with Phase 3 initiation expected in Q4 2026.
Implication: Signals pipeline investment and modality expansion.

🧫 NCCN expands ANKTIVA use in NMIBC [3] [US • 17 Mar 2026]

https://immunitybio.com/immunitybio-announces-nccn-clinical-practice-guidelines-in-oncology-have-been-updated-to-include-anktiva-plus-bcg-for-patients-with-bcg-unresponsive-nmibc-with-papillary-only-disease/
Context: NCCN updated bladder cancer guidelines to include ANKTIVA plus BCG for papillary-only BCG-unresponsive NMIBC.
Key point: Recommendation is Category 2A and extends beyond the current FDA-approved indication.
Implication: May influence prescriber choice and payer reviews pending full data.

🫁 Candel shows durable survival tail in NSCLC [4] [US • 17 Mar 2026]

https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-reports-extended-survival-tail-observed
Context: CAN-2409 was evaluated in patients with advanced NSCLC with inadequate response to prior ICI therapy.
Key point: 50% of patients were alive at 24 months, with median overall survival around 25 months.
Implication: May influence prescriber choice and payer reviews pending full data.

☢️ Lantheus PDUFA delay for LNTH-2501 [5] [US • 17 Mar 2026]

https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-three-month-extension-pdufa-date-lnth-2501-ga
Context: LNTH-2501 is a Ga-68 edotreotide PET imaging kit for somatostatin receptor-positive neuroendocrine tumors.
Key point: FDA extended the PDUFA date by three months to review additional manufacturing information.
Implication: May influence prescriber choice and payer reviews pending full data.

🎯 Dizal reports positive Phase 3 in EGFR exon20 NSCLC [6] [21 Mar 2026]

https://www.prnewswire.com/news-releases/dizal-announces-positive-topline-phase-3-results-from-wu-kong28-study-evaluating-oral-once-daily-zegfrovy-sunvozertinib-vs-platinum-containing-chemo-doublet-in-first-line-non-small-cell-lung-cancer-nsclc-with-egfr-exon-20–302721366.html
Context: WU-KONG28 compared sunvozertinib monotherapy versus platinum-based chemotherapy in first-line EGFR exon20ins NSCLC.
Key point: The study met its primary endpoint with significant PFS improvement and superior secondary endpoints.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 CytomX reports encouraging CRC ADC data [7] [US • 16 Mar 2026]

https://ir.cytomx.com/news-releases/news-release-details/cytomxs-varsetatug-masetecan-epcam-probodyr-adc-continues
Context: Varsetatug masetecan is an EpCAM-targeting PROBODY ADC in late-line metastatic CRC.
Key point: Phase 1 expansion showed ORR up to 32% and median PFS around 7 months with manageable safety.
Implication: May influence prescriber choice and payer reviews pending full data.

🧠 Telix resubmits Pixclara NDA for glioma imaging [8] [US • 16 Mar 2026]

https://telixpharma.com/news-views/telix-resubmits-nda-to-u-s-fda-for-tlx101-px-pixclara-brain-cancer-imaging-candidate/
Context: TLX101-Px is an amino acid PET imaging agent for recurrent or progressive glioma.
Key point: NDA resubmission includes additional data to address a prior complete response letter.
Implication: May influence prescriber choice and payer reviews pending full data.

🤝 Voro and Daiichi Sankyo partner on tumor-activated ADCs [9] [US • 17 Mar 2026]

https://www.vorotx.com/post/voro-therapeutics-announces-research-collaboration-with-daiichi-sankyo-to-advance-primebody
Context: Collaboration focuses on developing masked ADCs using PrimeBody tumor-activation technology.
Key point: Platform aims to improve therapeutic index through tumor-selective activation.
Implication: Signals pipeline investment and modality expansion.

🧬 Remix gains Fast Track for MYB degrader in ACC [10] [US • 19 Mar 2026]

https://www.remixtx.com/fda-fast-track-designation-for-rem-422/
Context: REM-422 is a first-in-class small molecule MYB mRNA degrader for adenoid cystic carcinoma.
Key point: FDA granted Fast Track based on early clinical activity and unmet need.
Implication: Signals pipeline investment and modality expansion.

Why it matters

• Imfinzi (AstraZeneca) [1] and givastomig (NovaBridge) [2]: Gastric cancer treatment is evolving rapidly, with both approved immunotherapy combinations and emerging CLDN18.2-targeted strategies.
• ZEGFROVY (Dizal) [6] and CAN-2409 (Candel) [4]: NSCLC innovation continues across both targeted therapy and immune-modulating approaches in resistant disease.
• Varsetatug masetecan (CytomX) [7] and PrimeBody ADCs (Voro/Daiichi) [9]: ADC development remains active, spanning both clinical validation and next-generation platform design.
• TLX101-Px (Telix) [8] and LNTH-2501 (Lantheus) [5]: Imaging and radiopharmaceutical development continue to advance, with ongoing regulatory activity.
• REM-422 (Remix) [10] and ANKTIVA (ImmunityBio) [3]: Regulatory and guideline updates in high unmet-need settings are shaping near-term clinical adoption.

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