Immunology Video Recap—October 22, 2025

In this video, we take a closer look at the newest updates in immunology. Watch for recent approvals, promising pipeline results, and technology advances shaping the next wave of treatments.

Watch Our Video Summary Capturing Top Immunology News from the Last Two Weeks

Top Stories Covered in This Video

🧬 Everest Medicines Publishes Positive Phase III Data for Etrasimod in UC [1] [09 Oct 2025]

https://www.everestmedicines.com/news/everest-medicines-announces-publication-of/4af6c384-88b5-40a8-93f1-85a5bde6c12d
Context: Everest Medicines’ etrasimod shows significant clinical and endoscopic improvements in a Phase III UC trial in Asia.
Key Point: Etrasimod demonstrated a 51.9% mucosal healing rate and a 45.5% mucosal normalization rate after 52 weeks.
Implication: Etrasimod could fill a critical treatment gap in UC, especially in the Asian patient population.

💊 FDA Approves Updated Indication for Upadacitinib in IBD [2] [13 Oct 2025]

https://www.pharmacytimes.com/view/fda-approves-updated-indication-for-upadacitinib-in-patients-with-ibd
Context: FDA has approved upadacitinib for use before TNF blockers in certain IBD patients.
Key Point: Upadacitinib can now be used as a first-line treatment in patients with Crohn’s disease and ulcerative colitis who have not previously received TNF blockers.
Implication: This approval provides more treatment options for patients with moderate-to-severe IBD.

👶 FDA Approves SIMPONI® for Pediatric Ulcerative Colitis [3] [07 Oct 2025]

https://www.jnj.com/media-center/press-releases/u-s-fda-approves-simponi-golimumab-for-the-treatment-of-pediatric-ulcerative-colitis
Context: FDA expands SIMPONI® indication to treat pediatric patients with UC.
Key Point: SIMPONI® is now the only approved medication to offer monthly maintenance dosing for children with UC.
Implication: This approval provides pediatric UC patients with a new effective treatment option, improving quality of life and disease management.

⚖️ FDA Approves Cemiplimab for High-Risk CSCC [4] [13 Oct 2025]

https://www.dermatologytimes.com/view/fda-approves-cemiplimab-as-adjuvant-immunotherapy-for-high-risk-cscc
Context: Cemiplimab is now FDA-approved as the first adjuvant immunotherapy for high-risk CSCC patients post-surgery and radiation.
Key Point: Cemiplimab reduced disease recurrence by 68%, significantly improving disease-free survival.
Implication: Cemiplimab offers a new standard of care for high-risk CSCC, potentially reducing recurrence risks and improving survival rates.

🌍 Regeneron’s Cemiplimab Recommended for EU Approval for High-Risk CSCC [5] [17 Oct 2025]

https://newsroom.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-recommended-eu-approval-chmp-adjuvant
Context: CHMP has recommended cemiplimab for high-risk cutaneous squamous cell carcinoma (CSCC) in the adjuvant setting.
Key Point: Cemiplimab reduced the risk of disease recurrence by 68% in high-risk CSCC patients.
Implication: Cemiplimab’s recommendation for EU approval could expand access to this important treatment for high-risk CSCC patients.

🔬 Replimune’s RP1 BLA Resubmission Accepted by FDA [6] [17 Oct 2025]

https://www.dermatologytimes.com/view/fda-accepts-rp1-bla-resubmission-for-advanced-melanoma
Context: The FDA has accepted Replimune’s RP1 BLA resubmission for advanced melanoma treatment.
Key Point: The resubmission includes additional data to address regulatory concerns, with a PDUFA date set for April 2026.
Implication: RP1 could offer a breakthrough treatment for PD-1 refractory melanoma, adding a new weapon in the fight against this challenging cancer.

💉 Roche’s Gazyva®/Gazyvaro® Recommended for Lupus Nephritis by CHMP [7] [17 Oct 2025]

https://www.roche.com/media/releases/med-cor-2025-10-17
Context: CHMP has recommended Gazyva®/Gazyvaro® for lupus nephritis, based on Phase II and III trial data.
Key Point: Gazyva®/Gazyvaro® demonstrated a complete renal response in lupus nephritis patients, offering a new potential treatment option.
Implication: Gazyva®/Gazyvaro® could help manage lupus nephritis, preventing kidney damage and delaying disease progression.

🔬 FDA Approves Roche’s Gazyva®/Gazyvaro® for Lupus Nephritis Treatment [8] [20 Oct 2025]

https://www.roche.com/media/releases/med-cor-2025-10-20
Context: FDA has approved Gazyva®/Gazyvaro® for lupus nephritis treatment, offering improved disease control and easier administration.
Key Point: This approval provides a new therapeutic option for patients, particularly those who have not responded to other therapies.
Implication: Gazyva®/Gazyvaro® could become a new standard of care for lupus nephritis, offering effective disease control and a more convenient treatment regimen.

Why it matters

Etrasimod by Everest Medicines demonstrates significant clinical improvements for UC patients, especially in Asia, where treatment options have been limited [1].
Upadacitinib offers a new option for IBD patients, especially those who cannot receive TNF blockers, enhancing treatment flexibility [2].
SIMPONI® provides a new and convenient option for pediatric UC patients, improving disease management with monthly maintenance doses [3].
Cemiplimab introduces a revolutionary immunotherapy for high-risk CSCC, improving disease-free survival and offering a new standard of care [4].
Cemiplimab’s recommendation for EU approval for CSCC could offer expanded treatment options for patients across Europe [5].
RP1 has the potential to offer a breakthrough treatment for melanoma, especially for patients who have failed PD-1 therapies, filling an unmet need [6].
Gazyva®/Gazyvaro® offers a promising new option for lupus nephritis, with FDA approval now granted, providing a more convenient treatment [7][8].

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FAQ

What is the significance of the ENLIGHT UC study for etrasimod?

The ENLIGHT UC study provided pivotal data showing that etrasimod significantly improves clinical and endoscopic outcomes in UC patients, filling a treatment gap in Asia [1].

What does the upadacitinib label update mean for IBD patients?

The update allows upadacitinib to be used as a first-line treatment option for patients with moderate-to-severe IBD who cannot use TNF blockers, offering more treatment options [2].

How does SIMPONI® benefit pediatric UC patients?

SIMPONI® now provides an FDA-approved monthly maintenance dose for pediatric UC patients, offering a more manageable treatment regimen [3].

How does cemiplimab impact CSCC patients?

Cemiplimab significantly reduces the risk of disease recurrence in high-risk CSCC patients, improving disease-free survival and offering a much-needed treatment option for this population [4].

What does the EU recommendation for cemiplimab mean for CSCC patients?

The EU recommendation for cemiplimab means expanded access to this treatment for high-risk CSCC patients in Europe, offering a new approach to managing the disease [5].

What is the potential of RP1 for advanced melanoma?

RP1, when combined with nivolumab, could provide a much-needed treatment for advanced melanoma, especially for patients who have failed PD-1 therapies [6].

How will Gazyva®/Gazyvaro® help lupus nephritis patients?

Gazyva®/Gazyvaro® offers an effective treatment for lupus nephritis, improving renal responses and providing a new option for patients who have not responded to other therapies [7][8].

Entities / Keywords

Everest Medicines; Etrasimod; ulcerative colitis; AbbVie; Upadacitinib; inflammatory bowel disease; Johnson & Johnson; SIMPONI®; pediatric ulcerative colitis; Regeneron; Cemiplimab; cutaneous squamous cell carcinoma; Replimune; RP1; advanced melanoma; Roche; Gazyva®; Gazyvaro®; lupus nephritis; FDA approval.