Press Release: Libtayo (Cemiplimab) Approved as First Adjuvant Immunotherapy for High-Risk cSCC

Atopic Dermatitis Breakthrough: Precision Treatment and the Promise of AdvanceAD-Tx™

Disclaimer: This podcast is not sponsored by or associated with any of the products mentioned in today's episode. Episode 15 Drop: Atopic Dermatitis Breakthrough: Precision Treatment and the Promise of AdvanceAD-Tx™ In this episode of Skinfluenced: The Skin Podcast, we explore a groundbreaking advancement in the management of moderate-to-severe atopic dermatitis (AD). Castle Biosciences’ new AdvanceAD-Tx™ test, launched THIS MONTH, introduces precision medicine to dermatology with a 487-gene expression profile (GEP) that decodes each patient’s unique immune biology. By classifying results into different profile groups, clinicians can now identify which patients are more likely to respond to specific systemic therapies—before treatment even begins. We're breaking down: * The IDENTITY study which showed how patients can now get EASI-90 nearly 4X faster * How this innovation could transform treatment selection, improve patient outcomes, and redefine the role of molecular testing in dermatology. ⚠️ Educational purposes only. Not medical advice. Link to Source(s): Castle Biosciences, Inc. Castle Biosciences Launches AdvanceAD-Tx™ to Help Guide Systemic Treatment Decision Making in Patients with Moderate-to-Severe Atopic Dermatitis. Accessed November 11, 2025. https://ir.castlebiosciences.com/news/news-details/2025/Castle-Biosciences-Launches-AdvanceAD-Tx-to-Help-Guide-Systemic-Treatment-Decision-Making-in-Patients-with-Moderate-to-Severe-Atopic-Dermatitis/default.aspx [https://ir.castlebiosciences.com/news/news-details/2025/Castle-Biosciences-Launches-AdvanceAD-Tx-to-Help-Guide-Systemic-Treatment-Decision-Making-in-Patients-with-Moderate-to-Severe-Atopic-Dermatitis/default.aspx] Castle Biosciences, Inc. Castle Biosciences Launches AdvanceAD-Tx™ to Help Guide Systemic Treatment Decision Making in Patients with Moderate-to-Severe Atopic Dermatitis. News Release. November 3, 2025. Chiesa Fuxench, Zelma C., et al. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. Journal of Investigative Dermatology. 2019; 139: 583–590. Silverberg, Jonathan I., et al. Patient burden and quality of life in atopic dermatitis in US adults: A population-based cross-sectional study. Annals of Allergy, Asthma & Immunology. 2018; 121(3): 340-347. Silverberg, Jonathan I., et al. The 487-gene expression profile test guides systemic therapy selection to improve outcomes for patients with atopic dermatitis: Results from a prospective, multi-center trial. Castle Biosciences AdvanceAD-Tx™ Launch Slide Deck. November 2025. The Derm Digest. Castle Biosciences Rolls Out AdvanceAD-Tx. Accessed November 11, 2025. https://thedermdigest.com/castle-biosciences-rolls-out-advancead-tx/?utm [https://www.google.com/search?q=https://thedermdigest.com/castle-biosciences-rolls-out-advancead-tx/%3Futm]_source=Klaviyo&utm_medium=campaign&_kx=LStbfMDiK_dFORiyt1p_kkItQ6IXDv9wQWWp60o95yV8qS2-9Wbebg-OUZpTxSvC.TYhhHR

Press Release: Libtayo (Cemiplimab) Approved as First Adjuvant Immunotherapy for High-Risk cSCC

Disclaimer: This podcast is not sponsored by or associated with any of the products mentioned in today's episode. In this episode of Skinfluenced: The Skin Podcast, we break down the FDA’s recent approval of Libtayo® (Cemiplimab-rwlc) as the first and only adjuvant immunotherapy for patients with high-risk cutaneous squamous cell carcinoma (cSCC) following surgery and radiation. Join us as we discuss:🧬 The pivotal trial showing improved disease-free survival in high-risk cSCC💉 The evolving role of PD-1 blockade in post-surgical skin cancer management🧠 How this approval changes the treatment landscape for patients at risk of recurrence This landmark decision represents a major step forward in skin cancer care—bringing immunotherapy into the adjuvant setting and offering new hope for patients facing aggressive or recurrent cSCC. Link to Source(s): American Association for Cancer Research. Immunotherapy Approved for Preventing Recurrence of Certain Skin Cancers. Accessed October 22, 2025. https://tinyurl.com/ywpynwfn [https://www.aacr.org/patients-caregivers/progress-against-cancer/immunotherapy-approved-for-preventing-recurrence-of-certain-skin-cancers/] American Journal of Managed Care. FDA Approves Cemiplimab as First & Only Adjuvant Immunotherapy for High-Risk cSCC. Accessed October 22, 2025. https://tinyurl.com/5b4s6jb7 [https://www.ajmc.com/view/fda-approves-cemiplimab-as-first-only-adjuvant-immunotherapy-for-high-risk-cscc] Dermatology Advisor. FDA Approves Libtayo for Adjuvant Treatment of High-Risk cSCC. Accessed October 22, 2025. https://tinyurl.com/58h5cckn [https://www.dermatologyadvisor.com/news/fda-approves-libtayo-for-adjuvant-treatment-of-high-risk-cscc/] Derm Digest. FDA Approves Cemiplimab to Treat cSCC With High Risk of Recurrence After Surgery and Radiation. Accessed October 22, 2025. https://tinyurl.com/2s9jjc53 [https://thedermdigest.com/fda-approves-cemiplimab-to-treat-cscc-with-high-risk-of-recurrence-after-surgery-and-radiation/?utm_source=Klaviyo&utm_medium=campaign&_kx=LStbfMDiK_dFORiyt1p_kkItQ6IXDv9wQWWp60o95yV8qS2-9Wbebg-OUZpTxSvC.TYhhHR] Journal of Clinical Oncology. Adjuvant Libtayo (cemiplimab) Significantly Improves Disease-Free Survival in Patients With High-Risk Cutaneous Squamous Cell Carcinoma. Published 2025; 43(16_suppl):6000. Accessed October 22, 2025. https://tinyurl.com/27ekuzch [https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.6000] New England Journal of Medicine. Adjuvant Cemiplimab for Cutaneous Squamous-Cell Carcinoma. Published 2025. Accessed October 22, 2025. https://tinyurl.com/4rynuvky [https://tinyurl.com/4rynuvky] OncLive. Dr. Patel on the FDA Approval of Adjuvant Cemiplimab for High-Risk Cutaneous Squamous Cell Carcinoma. Accessed October 22, 2025. https://tinyurl.com/4kvzbv8z [https://www.onclive.com/view/dr-patel-on-the-fda-approval-of-adjuvant-cemiplimab-for-high-rish-cutaneous-squamous-cell-carcinoma] Oncology Nursing Society. FDA Approves Cemiplimab-rwlc for Adjuvant Treatment of High-Risk Cutaneous Squamous Cell Carcinoma. Published October 2025. Accessed October 22, 2025. https://tinyurl.com/4ne9rsv3 [https://www.ons.org/publications-research/voice/news-views/10-2025/fda-approves-cemiplimab-rwlc-adjuvant-treatment] Regeneron Pharmaceuticals. Adjuvant Libtayo (cemiplimab) Significantly Improves Disease-Free Survival in Phase 3 Trial. Accessed October 22, 2025. https://tinyurl.com/3a9m5u6c [https://investor.regeneron.com/news-releases/news-release-details/adjuvant-libtayor-cemiplimab-significantly-improves-disease-free] Regeneron Pharmaceuticals. FDA Approves Libtayo (cemiplimab-rwlc) in the U.S. as the First and Only Adjuvant Immunotherapy for High-Risk cSCC. Accessed October 22, 2025. https://tinyurl.com/2hfs59k2 [https://newsroom.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-rwlc-approved-us-first-and-only] Regeneron Pharmaceuticals. Libtayo (cemiplimab) Phase 3 Data: Adjuvant Treatment Post-Surgery and Radiation. Accessed October 22, 2025. https://tinyurl.com/yx5xkzcr [https://newsroom.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-phase-3-data-adjuvant-treatment-post] Regeneron Pharmaceuticals. Libtayo Full Prescribing Information. Accessed October 22, 2025. https://tinyurl.com/86w7ydjn [https://www.regeneron.com/downloads/libtayo_fpi.pdf] Regeneron Pharmaceuticals. Libtayo Medication Guide. Accessed October 22, 2025. https://tinyurl.com/432jx77u [https://www.regeneron.com/downloads/libtayo-medication-guide.pdf] ScienceDirect. Induction of Natural Cytotoxicity by Interferon: Studies on the Mechanism of Action. Trends in Biochemical Sciences. Published 1985. Accessed October 22, 2025. https://tinyurl.com/589swev2 [https://www.sciencedirect.com/science/article/abs/pii/0168952585900897] #SCC #skincancer #skincancertreatment #Dermatology #SkinHealth #NewTreatments #FDAApproved #Therapies #ClinicalGuidelines #FDAApproval #SkinScience #EvidenceBasedMedicine #SCCManagement #DermUpdate #SkinScience #Dermatology #DermatologyProvider #Dermatologist #PhysicianAssistant #PhysicianAssociate #NursePractitioner #SkinfluencedPodcast #DermatologyPodcast

Press Release: Zoryve (roflumilast) 0.05% Cream Approved for Atopic Dermatitis in Ages 2-5

Disclaimer: This podcast is not sponsored by or associated with any of the products mentioned in today's episode. In this episode of Skinfluenced: The Skin Podcast, we break down the FDA’s latest approval of ZORYVE® (roflumilast) Cream 0.05%, marking a new topical treatment option for young children living with atopic dermatitis. Join us as we discuss: 🌿 Clinical trial data showing safety and efficacy in patients aged 2–5 years 💊 How PDE-4 inhibition with roflumilast differs from current treatment options 🧴 What this means for real-world management of pediatric eczema This exciting update highlights continued innovation in pediatric dermatology and expands therapeutic options for our youngest patients. Link to Source(s): Arcutis. FDA Approves Arcutis’ ZORYVE (roflumilast) Cream 0.05 for the Treatment of Atopic Dermatitis in Children Ages 2 to 5. Published October 6, 2025. Accessed October 8, 2025. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-cream-0-05-for-the-treatment-of-atopic-dermatitis-in-children-ages-2-to-5/ [https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-cream-0-05-for-the-treatment-of-atopic-dermatitis-in-children-ages-2-to-5/?utm_source=chatgpt.com] Arcutis Biotherapeutics. FDA Approves Arcutis’ ZORYVE (roflumilast) Cream 0.05 Treatment. Published October 6, 2025. Accessed October 8, 2025. https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-005-treatment [https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-005-treatment] HCPLive. FDA Approves Roflumilast (Zoryve) Cream 0.05 for Atopic Dermatitis in Children Aged 2-5 Years. Published October 6, 2025. Accessed October 8, 2025. https://www.hcplive.com/view/fda-approves-roflumilast-zoryve-cream-0-05-for-atopic-dermatitis-in-children-aged-2-5-years [https://www.hcplive.com/view/fda-approves-roflumilast-zoryve-cream-0-05-for-atopic-dermatitis-in-children-aged-2-5-years?utm_source=chatgpt.com] HCPLive. Roflumilast Cream 0.05% Effective for Atopic Dermatitis in Patients Aged 2-5 Years. Published February 22, 2025. Accessed October 8, 2025. https://www.hcplive.com/view/roflumilast-cream-0-05-effective-atopic-dermatitis-patients-aged-2-5-years [https://www.hcplive.com/view/roflumilast-cream-0-05-effective-atopic-dermatitis-patients-aged-2-5-years?utm_source=chatgpt.com] HCPLive. Significance of Roflumilast Approval in Atopic Dermatitis Children — Lawrence Eichenfield, MD. Published October 8, 2025. Accessed October 8, 2025. https://www.hcplive.com/view/significance-roflumilast-approval-atopic-dermatitis-children-lawrence-eichenfield-md [https://www.hcplive.com/view/significance-roflumilast-approval-atopic-dermatitis-children-lawrence-eichenfield-md] HMP Global Learning Network / The Derm. FDA Alerts: FDA Approves Roflumilast Cream 0.05 Treatment for Atopic Dermatitis in Children. Published October 6, 2025. Accessed October 8, 2025. https://www.hmpgloballearningnetwork.com/site/thederm/fda-alerts/fda-approves-roflumilast-cream-005-treatment-atopic-dermatitis-children [https://www.hmpgloballearningnetwork.com/site/thederm/fda-alerts/fda-approves-roflumilast-cream-005-treatment-atopic-dermatitis-children] The Derm Digest. U.S. FDA Approves Roflumilast Cream 0.05 for AD in Kids Aged 2 to 5. Published October 6, 2025. Accessed October 8, 2025. https://thedermdigest.com/u-s-fda-approves-roflumilast-cream-0-05-for-ad-in-kids-aged-2-to-5 [https://thedermdigest.com/u-s-fda-approves-roflumilast-cream-0-05-for-ad-in-kids-aged-2-to-5] Zoryve HCP. [Homepage]. Accessed October 8, 2025. https://www.zoryvehcp.com/ [https://www.zoryvehcp.com/] #AD #atopicdermatitis #Dermatology #SkinHealth #NewTreatments #FDAApproved #topicalTherapies #ClinicalGuidelines #FDAApproval #UTDDermatology #SkinScience #EvidenceBasedMedicine #ADManagement #DermUpdate #SkinScience #Dermatology #DermatologyProvider #Dermatologist #CosmeticDermatology #Aesthetics #PhysicianAssistant #PhysicianAssociate #NursePractitioner #SkinfluencedPodcast #DermatologyPodcast

Press Release: FDA Approves Remibrutinib (Rhapsido) for Chronic Spontaneous Urticaria

Disclaimer: This podcast is not sponsored by or associated with any of the products mentioned in today’s episode. In this episode of Skinfluenced: The Skin Podcast, we review the FDA’s September 30, 2025 approval of remibrutinib (Rhapsido, Novartis), the first oral BTK inhibitor indicated for chronic spontaneous urticaria (CSU). We’ll walk through the press releases, clinical trial data, and recent publications highlighting its efficacy, safety, and potential impact on treatment pathways for CSU. Link to Source(s): The American Journal of Managed Care (AJMC). FDA Approves Remibrutinib for Chronic Spontaneous Urticaria. Published September 30, 2025. Accessed October 1, 2025. https://www.ajmc.com/view/fda-approves-remibrutinib-for-chronic-spontaneous-urticaria [https://www.ajmc.com/view/fda-approves-remibrutinib-for-chronic-spontaneous-urticaria] BioSpace. Novartis Secures First FDA Approval of Oral BTK Inhibitor for Chronic Hives. Published September 30, 2025. Accessed October 1, 2025. https://www.biospace.com/fda/novartis-secures-first-fda-approval-of-oral-btk-inhibitor-for-chronic-hives [https://www.biospace.com/fda/novartis-secures-first-fda-approval-of-oral-btk-inhibitor-for-chronic-hives] ClinicalTrials.gov. A Study to Assess the Efficacy and Safety of Remibrutinib in Participants With Chronic Spontaneous Urticaria (NCT05030311). Updated 2025. Accessed October 1, 2025. https://clinicaltrials.gov/study/NCT05030311 [https://clinicaltrials.gov/study/NCT05030311] ClinicalTrials.gov. A Study of Remibrutinib in Chronic Spontaneous Urticaria (NCT05032157). Updated 2025. Accessed October 1, 2025. https://clinicaltrials.gov/study/NCT05032157 [https://clinicaltrials.gov/study/NCT05032157] Novartis. Novartis Receives FDA Approval for Rhapsido (Remibrutinib), the Only Oral Targeted BTKi Treatment for Chronic Spontaneous Urticaria (CSU). Published September 30, 2025. Accessed October 1, 2025. https://www.novartis.com/us-en/news/media-releases/novartis-receives-fda-approval-rhapsido-remibrutinib-only-oral-targeted-btki-treatment-chronic-spontaneous-urticaria-csu [https://www.novartis.com/us-en/news/media-releases/novartis-receives-fda-approval-rhapsido-remibrutinib-only-oral-targeted-btki-treatment-chronic-spontaneous-urticaria-csu] Practical Dermatology. FDA Approves Remibrutinib for Adults With CSU. Published September 30, 2025. Accessed October 1, 2025. https://practicaldermatology.com/news/fda-approves-remibrutinib-for-adults-with-csu/2483590/ [https://practicaldermatology.com/news/fda-approves-remibrutinib-for-adults-with-csu/2483590/] Reuters. US FDA Approves Novartis Drug for Skin Disease. Published September 30, 2025. Accessed October 1, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-novartis-drug-skin-disease-2025-09-30/ [https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-novartis-drug-skin-disease-2025-09-30/] ScienceDirect. Remibrutinib in Chronic Spontaneous Urticaria: Results From Clinical Trials. Published 2022. Accessed October 1, 2025. https://www.sciencedirect.com/science/article/pii/S0091674922011812 [https://www.sciencedirect.com/science/article/pii/S0091674922011812] The Derm Digest. Breaking News: The U.S. FDA Approves Remibrutinib (Rhapsido, Novartis) for CSU. Published September 30, 2025. Accessed October 1, 2025. https://thedermdigest.com/breaking-news-the-u-s-fda-approves-remibrutinib-rhapsido-novartis-for-csu/?utm_source=Klaviyo&utm_medium=campaign&_kx=LStbfMDiK_dFORiyt1p_kkItQ6IXDv9wQWWp60o95yV8qS2-9Wbebg-OUZpTxSvC.TYhhHR [https://thedermdigest.com/breaking-news-the-u-s-fda-approves-remibrutinib-rhapsido-novartis-for-csu/?utm_source=Klaviyo&utm_medium=campaign&_kx=LStbfMDiK_dFORiyt1p_kkItQ6IXDv9wQWWp60o95yV8qS2-9Wbebg-OUZpTxSvC.TYhhHR] Taylor & Francis Online. Remibrutinib for Chronic Spontaneous Urticaria: Clinical Impact and Future Directions. Published 2025. Accessed October 1, 2025. https://www.tandfonline.com/doi/abs/10.1080/1750743X.2025.2510892 [https://www.tandfonline.com/doi/abs/10.1080/1750743X.2025.2510892]

Press Release: Opzelura (ruxolitinib) 2% Cream Approved for Atopic Dermatitis in Ages 2 and Up

Disclaimer: This podcast is not sponsored by or associated with any of the products mentioned in today's episode. In this episode of Skinfluenced: The Skin Podcast, we review the brand new FDA approval of Opzelura® (ruxolitinib) cream 1.5% for children ages 2 and up with atopic dermatitis. This marks a major step forward in pediatric dermatology, offering the first topical JAK inhibitor option for younger patients with mild-to-moderate AD who need more than topical steroids or topical calcineurin inhibitors. We’ll discuss the clinical trial data from the TRuE-AD program, safety considerations, and where ruxolitinib cream may fit into the evolving treatment landscape for pediatric eczema. Tune in to learn what this means for providers, patients, and families navigating chronic AD care. #AtopicDermatitis #Eczema  #PediatricDermatology #Opzelura #Ruxolitinib #JAKInhibitor #Dermatology #SkinHealth #NewTreatments #FDAApproved #TopicalTherapies #ClinicalGuidelines #FDAApproval #EczemaTreatment #ADUpdate #SkinScience #EvidenceBasedMedicine #ADManagement #DermUpdate #SkinScience #Dermatology #DermatologyProvider #Dermatologist #CosmeticDermatology #Aesthetics #PhysicianAssistant #PhysicianAssociate #NursePractitioner #SkinfluencedPodcast #DermatologyPodcast Link to Source(s): Business Wire. Incyte Announces U.S. FDA Approval of Opzelura (Ruxolitinib) Cream, a Topical JAK Inhibitor, for Treatment of Atopic Dermatitis (AD). Published September 21, 2021. Accessed September 20, 2025. ⁠https://www.businesswire.com/news/home/20210921006072/en/Incyte-Announces-U.S.-FDA-Approval-of-Opzelura-ruxolitinib-Cream-a-Topical-JAK-Inhibitor-for-the-Treatment-of-Atopic-Dermatitis-AD⁠ [https://www.businesswire.com/news/home/20210921006072/en/Incyte-Announces-U.S.-FDA-Approval-of-Opzelura-ruxolitinib-Cream-a-Topical-JAK-Inhibitor-for-the-Treatment-of-Atopic-Dermatitis-AD] Contemporary Pediatrics. FDA Approves Ruxolitinib for Pediatric Atopic Dermatitis. Published July 29, 2025. Accessed September 20, 2025. ⁠https://www.contemporarypediatrics.com/view/fda-approves-ruxolitinib-for-pediatric-atopic-dermatitis⁠ [https://www.contemporarypediatrics.com/view/fda-approves-ruxolitinib-for-pediatric-atopic-dermatitis] Incyte. Incyte Announces FDA Approval of Opzelura (Ruxolitinib) Cream for Treatment of Vitiligo in Nonsegmental Patients 12 Years and Older. Published July 18, 2022. Accessed September 20, 2025. ⁠https://investor.incyte.com/node/23156/pdf⁠ [https://investor.incyte.com/node/23156/pdf] Incyte. Incyte Announces Positive Topline Results From Pivotal Phase 3 TRuE-AD Clinical Trial Program Evaluating Ruxolitinib Cream for Atopic Dermatitis. Published December 15, 2019. Accessed September 20, 2025. ⁠https://investor.incyte.com/node/23376/pdf⁠ [https://investor.incyte.com/node/23376/pdf] Incyte. Incyte Announces FDA Approval of Opzelura (Ruxolitinib) Cream for Treatment of Atopic Dermatitis in Pediatric Patients Ages ≥2 Years. Published July 29, 2025. Accessed September 20, 2025. ⁠https://investor.incyte.com/node/25636/pdf⁠ [https://investor.incyte.com/node/25636/pdf] Incyte. Incyte Announces FDA Approval of Opzelura (Ruxolitinib) Cream for Treatment of Nonsegmental Vitiligo in Patients 12 Years and Older. Published July 18, 2022. Accessed September 20, 2025. ⁠https://investor.incyte.com/node/25226/pdf⁠ [https://investor.incyte.com/node/25226/pdf] Pharmacy Times. FDA Approves 1.5% Ruxolitinib Cream for Pediatric Atopic Dermatitis. Published July 29, 2025. Accessed September 20, 2025. ⁠https://www.pharmacytimes.com/view/fda-approves-1-5-ruxolitinib-cream-for-pediatric-atopic-dermatitis⁠ [https://www.pharmacytimes.com/view/fda-approves-1-5-ruxolitinib-cream-for-pediatric-atopic-dermatitis] The American Journal of Managed Care (AJMC). FDA Approves Ruxolitinib Cream for Patients as Young as 2 Years With Atopic Dermatitis. Published July 29, 2025. Accessed September 20, 2025. ⁠https://www.ajmc.com/view/fda-approves-ruxolitinib-cream-for-patients-as-young-as-2-years-with-atopic-dermatitis⁠ [https://www.ajmc.com/view/fda-approves-ruxolitinib-cream-for-patients-as-young-as-2-years-with-atopic-dermatitis]