--- title: PDR Drug Update - December 2025 description: The PDR Labeling Updates provide physicians with the latest FDA recalls, warnings and approval information - available in PDR's monthly eDrug Update --- # December 2025 PDR Drug Update  Type Drug Name Here Search - Lead Story - Latest FDA News - FDA Drug Information Changes - FDA Safety - Labeling Updates Lead Story ##### **Steroid-Free Treatment for Chronic Skin Condition ** Individuals who have experienced hand eczema for six or more months may be diagnosed with an inflammatory skin condition known as chronic hand eczema (CHE). Until recently, there were no FDA-approved treatments specifically indicated for treating CHE. While therapeutic options such as emollients or highly potent topical steroids have existed, the results provided by those choices have often been unsatisfactory for patients. The unmet need of these individuals has created a demand for novel modes of effective and well-tolerated treatments suited to the severity and scope of the condition. The complexity and impact of CHE are significant. Up to 10% of the population experiences the skin disease. Symptoms such as itchy, painful, blistered, swollen, and fissured skin on the hands and wrists can be highly debilitating. In addition to the impediment of daily activities, patients also contend with psychological burdens stemming from the physical and social struggles. CHE may develop in multiple ways, often with a combination of factors contributing to triggering its occurrence. Irritant contact dermatitis, due to skin exposure to solvents, moisture, detergents, and other potentially irritating substances, is one common expression of hand eczema. Another subtype is atopic hand eczema, which occurs when there is hypersensitivity to certain chemicals, such as latex, metals, or preservative ingredients. A mainstay therapy for CHE has been topical steroids. Unfortunately, long-term use for patients often becomes unfeasible as common adverse effects negate the benefits the medications offer. Issues such as tachyphylaxis or skin atrophy may arise, leading patients to stop using their treatment. A remedy for this situation is the introduction of novel topical medications, including a new class of medication using small-molecule drugs. The recent approval of [Anzupgo (delgocitinib)](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219155s000lbl.pdf) brings one such advancement to providers who need to offer alternative approaches to their patients. The active ingredient delgocitinib is a pan-Janus Kinase (JAK) inhibitor. By targeting JAK signaling pathways, it modulates cytokine pathways involved in CHE. When inflammatory cytokines are blocked, the immune response in CHE can be lessened. It is a steroid-free option that has the potential to raise the standard of care that can be provided to adult patients who need to manage the difficulties of living with moderate to severe CHE. Clinical trial results that led to FDA approval of Anzupgo showed that in adults with moderate to severe CHE, twice-daily delgocitinib 20mg/g cream improved the signs and symptoms of CHE and showed positive outcomes over 16 weeks. Subsequent study was also conducted to determine the efficacy and safety of the medication in adolescents and achieved similarly successful results. This may mean the medication's future could include an expanded indication for a wider population. As research continues, more will be learned about the clinical benefits of delgocitinib in the treatment of CHE. Stay informed about emergent drug information, including treatment options for dermatological conditions, by exploring [PDR by ConnectiveRx](https://www.pdr.net/?hsLang=en). You can also stay current by using the official PDR app, [*mobile*PDR](https://www.pdr.net/mobilepdr/?hsLang=en), which is available for free from your preferred app store. Latest FDA News ### FDA New Approvals ##### Darzalex Faspro The FDA has granted traditional approval to Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide, and dexamethasone for the treatment of newly diagnosed light chain amyloidosis. [Learn more about Darzalex Faspro](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-daratumumab-and-hyaluronidase-fihj-newly-diagnosed-light-chain) ##### Hyrnuo The FDA has approved Hyrnuo (sevabertinib), an oral, reversible, tyrosine kinase inhibitor, for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. [Learn more about Hyrnuo](https://www.bayer.com/en/us/news-stories/hyrnuo) ##### Imdelltra The FDA has converted the prior accelerated approval to a full approval for Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. [Learn more about Imdelltra](https://www.amgen.com/newsroom/press-releases/2025/11/fda-grants-full-approval-to-amgens-imdelltra-in-extensive-stage-small-cell-lung-cancer) ##### Komzifti The FDA has approved Komzifti (ziftomenib) for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible *NPM1* mutation who have no satisfactory alternative treatment options. [Learn more about Komzifti](https://ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-and-kyowa-kirin-announce-fda-approval-komziftitm) ##### Kygevvi The FDA has approved Kygevvi (doxecitine/doxribtimine) for the treatment of adults and pediatric patients living with thymidine kinase 2 deficiency, with an age of symptom onset on or before 12 years. [Learn more about Kygevvi](https://www.ucb.com/newsroom/press-releases/article/us-fda-approves-kygevvitm-doxecitine-and-doxribtimine-the-first-and-only-treatment-for-adults-and-children-living-with-thymidine-kinase-2-deficiency-tk2d) ##### Poherdy The FDA has approved Poherdy (pertuzumab-dpzb) injection as an interchangeable biosimilar biological product to Perjeta (pertuzumab). Poherdy (pertuzumab-dpzb) is the first biosimilar approved for Perjeta (pertuzumab).  [Learn more about Poherdy](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761450s000lbl.pdf) ##### Redemplo The FDA has approved Redemplo (plozasiran), a small interfering RNA medicine, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome. [Learn more about Redemplo](https://arrowheadpharma.com/news-press/arrowhead-pharmaceuticals-announces-fda-approval-of-redemplo-plozasiran-to-reduce-triglycerides-in-adults-with-familial-chylomicronemia-syndrome-fcs/) ### FDA New Indications ##### Darzalex Faspro The FDA has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) as a single-agent treatment for adult patients with high-risk smoldering multiple myeloma. [Learn more about Darzalex Faspro](https://www.jnj.com/media-center/press-releases/darzalex-faspro-is-the-first-and-only-treatment-approved-by-the-u-s-fda-for-patients-with-high-risk-smoldering-multiple-myeloma) ##### Epkinly + R2 The FDA has approved Epkinly (epcoritamab-bysp) in combination with rituximab and lenalidomide (R2) for adult patients with relapsed or refractory follicular lymphoma. [Learn more about Epkinly + R2](https://ir.genmab.com/news-releases/news-release-details/genmab-announces-epkinlyr-epcoritamab-bysp-combination-rituximab) ##### Eylea HD The FDA has approved Eylea HD (aflibercept) injection 8mg for the treatment of patients with macular edema following retinal vein occlusion with up to every 8-week dosing after an initial monthly dosing period. [Learn more about Eylea HD](http://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-approved-fda-treatment) ##### Koselugo The FDA has approved Koselugo (selumetinib), an oral, selective MEK inhibitor, for the treatment of adult patients with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. [Learn more about Koselugo](https://www.astrazeneca.com/media-centre/press-releases/2025/koselugo-selumetinib-approved-in-the-us.html) FDA Drug Information Changes ### FDA Labeling Changes ##### Elevidys The FDA has approved updated prescribing information for Elevidys (delandistrogene moxeparvovec-rokl). The changes include the addition of a boxed warning to the product to alert patients and prescribers to its risk of serious liver toxicities and risk of death. In addition, the use of Elevidys was limited to ambulatory Duchenne patients aged 4 years and older with a confirmed mutation in the Duchenne muscular dystrophy gene. Following these labelling changes, Elevidys can no longer be used in non-ambulatory patients. [Learn more about Elevidys](https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-announces-fdas-approval-updated-elevidys-prescribing) ### FDA New Dosing ##### Eylea HD The FDA has approved Eylea HD (aflibercept) injection every 4-week (monthly) dosing for some patients who may benefit from resuming this dosing schedule across approved indications: wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, and retinal vein occlusion. [Learn more about Eylea HD](http://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-approved-fda-treatment) FDA Safety ### FDA Recalls ##### Fresenius Kabi Famotidine Fresenius Kabi is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of famotidine injection, USP, 20mg/2mL (10mg/mL), 2/mL fill in a 2mL vial. This recall is being performed to the user level. [Learn more about the Fresenius Kabi famotidine recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-three-lots-famotidine-injection-usp-20-mg-2-ml-10) ##### Otsuka ICU Medical Potassium Chloride Otsuka ICU Medical is issuing a voluntary recall to the user level, for a mislabeled lot of potassium chloride injection 20mEq, NDC 0990-7077-14. The overwrap label of lot 1030613, expiration date: 09-30-2026 may incorrectly identify the product as potassium chloride injection 10mEq with NDC 0990-7074-26. [Learn more about the Otsuka ICU Medical potassium chloride recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-20-meq-potassium-chloride-injection-due) ### FDA REMS ##### Blenrep The FDA has approved a REMS for Blenrep (belantamab mafodotin-blmf). The goal of the Blenrep REMS is to mitigate the risk of ocular toxicity. Prescribers monitor patients for ocular toxicity by assessing ophthalmic exam findings at baseline and during treatment as described in the Prescribing Information. [Learn more about Blenrep ](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761440s000lbl.pdf) Labeling Updates ##### Labeling Updates - No updates this month ```json { "@context" : "https://schema.org", "@id" : "https://www.pdr.net#website", "@type" : "Website", "name" : "", "potentialAction" : { "@type" : "SearchAction", "query-input" : "required name=search_term_string", "target" : { "@type" : "EntryPoint", "urlTemplate" : "https://www.pdr.net/?site-search={search_term_string}" } }, "publisher" : { "@id" : "https://www.pdr.net#organization" }, "url" : "https://www.pdr.net" } ``` ```json { "@context" : "https://schema.org", "@id" : "https://www.pdr.net/edrug-updates/dec2025#webpage", "@type" : "WebPage", "about" : { "@id" : "https://www.pdr.net#organization" }, "dateModified" : "2024-10-01T12:0000+0000", "datePublished" : "2025-11-26T13:3415+0000", "description" : "The PDR Labeling Updates provide physicians with the latest FDA recalls, warnings and approval information - available in PDR's monthly eDrug Update\t", "inLanguage" : null, "isPartOf" : { "@id" : "https://www.pdr.net#website" }, "name" : "PDR Drug Update - December 2025", "url" : "https://www.pdr.net/edrug-updates/dec2025" } ```