Expression of MAGE . Should you be in doubt, please contact us by email [email protected] or on our main phone number +31 208084414 Tebentafusp, sold under the brand name Kimmtrak, is an anti-cancer medication used to treat uveal melanoma (eye cancer).. The goal of this analysis was to increase understanding of the biological effects of tebentafusp and association between rash seen with treatment, CXCL10 and clinical outcomes in UM. The drug names link to NCI's Cancer Drug Information summaries. Tebentafusp is a bispecific gp100 peptide-HLA-A*02:01 fusion protein directed T cell receptor . Brand (Generic) Name: Kimmtrak (tebentafusp-tebn) Manufacturer: Immunocore; Date Approved: Jan. 25, 2022; Indication: for the treatment of adult patients who have unresectable or metastatic uveal melanoma that is HLA-A*02:01-positive; In the form of a printable coupon, rebate, savings card, free trial offers or free samples. Tumours can be made of benign cells (non-cancerous tumour) or malignant . 2021 Sep 23;385(13):1196-1206. link to original article PubMed NCT03070392; Also known as. Opzelura (ruxolitinib) Atopic Dermatitis . Tumour Type: Quviviq — Daridorexant, which goes by the brand name Quviviq, was approved on Jan. 7 to treat adults with insomnia. T cell receptor therapeutics are used to treat melanoma. 10 Jan. Daridorexant (Quviviq; Idorsia) . Most commonly, these are "non-preferred" brand drugs. Kimmtrak® NEW. Expression of MAGE, gp100 and . It is not known if Kimmtrak is safe and effective in children. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved 25 new oncology agents and new indications during the first few months of 2022. Important: The information below refers to products available in the United States that contain tebentafusp. B. Uveal Melanoma 1. Pacritinib is approved for treating adults with myelofibrosis (a disorder of bone marrow) with a platelet count below 50 × 109/L (1). 3: This drug is available at a higher level co-pay. They work by activating T cells to recognize and destroy tumor cells. Tebentafusp. 2 • overnight hospitalization. NDC #: 80446-0401-01. 3,068,856, serial number 78/040,636". Uveal (YOO-vee-uhl) melanoma. Uses for tebentafusp-tebn. Brand names beginning with the letter . The median onset time to ADA formation was 6-9 weeks after tebentafusp-tebn treatment. BRAND NAME New drugs indicated in red INGREDIENT CLASS CLASS XARACOLL Bupivacaine hydrochloride High Cost Other XEMBIFY Immune Globulin (SClg) Immune Globulin . Kimmtrak is only available as a brand name drug. Alternative Names: IMC-gp100; ImmTAC-gp100; KIMMTRAK; Monoclonal T cell receptor anti-CD3 scFv fusion protein . Commonly used brand name(s) In the U.S. Kimmtrak; Available Dosage Forms: Solution; Therapeutic Class: Antineoplastic Agent. This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows: ATC code. The member has HLA-A*02:01-positive unresectable or metastatic Uveal Melanoma and Kimmtrak (tebentafusp-tebn) may be used as monotherapy, if the member has tried and . Tebentafusp-tebn is the non-brand name of KIMMTRAK. Generic Name: tebentafusp-tebn. FDA calendar is a useful tool to know PDUFA dates related to FDA Approval and FDA Panel review of New Drug Applications, which are catalysts of Biotech Stocks. is required for the first cycle (days 1, 8, and 15) 1 • pain . Kimmtrak may be used alone or with other medications. It was under Priority Review. Kimmtrak (tebentafusp-tebn) is a bispecific fusion protein indicated to treat HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma, an aggressive cancer of the eye. Some INNs proposed in List 118 could be confused with a brand name, in particular: lenvervimab, praconase, setafrastat, tegavivint and tengonermin. Tebentafusp, sold under the brand name Kimmtrak, is an anti-cancer medication used to treat uveal melanoma (eye cancer). KIMMTRAK Tebentafusp-tebn Oncology KITABIS PAK Tobramycin nebu soln 300 MG/5ML Respiratory KRYSTEXXA Pegloticase Endocrine/Metabolic . Product name: Tebentafusp Biosimilar - Anti-CD3E mAb - Research Grade: Source: CAS 1874157-95-5: Species: Humanized: Purity >95%: Buffer: PBS buffer PH7.5: Delivery condition: Blue ice (+4°C) Delivery Time: . All rights reserved. Project Number: PC0290-000. To treat prostate-specific membrane antigen . KIMMTRAK CONNECT Enrollment Form : Medications: tebentafusp-tebn injection; iv (Kimmtrak) Injection; IV : Eligibility Requirements : Insurance Status: Must be uninsured or underinsured: Those with Part D Eligible? €25,278.28. HCPCS Code Brand Name Generic Name J3490 Apretude cabotegravir J3490 Korsuva difelikefalin J3590 Susvimo Ranibizumab port delivery system J3580 Tezpire tezepelumab-ekko J9999 Kimmtrak tebentafusp-tabn J3590 Vabysmo faricimab-svoa J3590 Enjaymo Sutimlimab-jome J9999 Opdualag Nivolumab and relatlimab-rmbw Drugs Approved for Melanoma. Immunocore had a target action date of February 23, 2022 for its Biologics License Application (BLA) regarding tebentafusp for treatment of HLA-A*02:01-positive adults with metastatic uveal melanoma (mUM). . If approved by the European Medicines Agency, KIMMTRAK will be the first and only treatment option approved in Europe to treat patients with unresectable or metastatic uveal melanoma. Tebentafusp-tebn injection is used to treat uveal melanoma (eye cancer) that has spread or cannot be removed by surgery in patients who are HLA-A*02:01 positive. . KIMMTRAK is the brand name of the generic drug tebentafusp-tebn. Pacritinib. Fam-trastuzumab deruxtecan-nxki Formula C6460H9972N1724O2014S44. €2,795.00. Legislators in the USA have been discussing reforms to reduce the high cost of brand-name drugs, which are much . Or Search By: Brand Name. Drug Name. Kimmtrak, (tebentafusp-tebn) injection, for intravenous use, is a prescription medicine used to treat the symptoms of Uveal Melanoma. Drug (brand name; company) Properties. Kimmtrak (tebentafusp-tebn) Injection; IV Kimyrsa (oritavancin) Injection; IV Kineret (anakinra) Injection . Code name: IMCgp100; Generic name: tebentafusp-tebn; Brand name: Kimmtrak Brand names beginning with the letter 'K . Active ingredients. 1 We operate solely under the TheSocialMedwork brand name. Immunocore had a target action date of February 23, 2022 for its Biologics License Application (BLA) regarding tebentafusp for treatment of HLA-A*02:01-positive adults with metastatic uveal melanoma (mUM). Cancer is a group of related diseases that result from the uncontrolled growth of cells. Tebentafusp 0 Star 0 Identification Summary Tebentafusp is a bispecific gp100 peptide-HLA-directed CD3 T cell engager used to treat unresectable or metastatic uveal melanoma. Use in Cancer Uveal melanoma is a rare, but aggressive disease in which cancer cells form in the tissues of the eye. Korsuva (difelikefalin) Chronic Kidney Disease Pruritus. 1 2 Helwick, Caroline (1 June 2008). (tebentafusp-tebn) with an off-label indication that is not sufficient in . The drug is available as a capsule in a dose of . NEWSLETTER; CONTACT US; FAQs Opzelura (ruxolitinib) Atopic Dermatitis. Reference number(s) 5149-A Kimmtrak 5149-A SGM 2022.docx © 2022 CVS Caremark. Apretude (cabotegravir extended-release injectable suspension) HIV/AIDS. References ↑ "US Trademark registration no. It was also being reviewed under the . Tebentafusp-tebn is the first and only FDA-approved therapy for unresectable or […] These cells accumulate and form a mass called a tumour. Tebentafusp is an ImmTAC molecule that targets a fragment of the melanocytes lineage-specific antigen gp100 280-288 (alternative names Melanocyte protein Pmel17, melanoma-associated ME20 antigen, ME20-M, [UniProtKB-P40967]) presented by HLA-A*02:01 [ 87 ]. It works by stimulating the immune system to kill cancer cells. Tebentafusp selectively cross-links T lymphocytes to the outside of the cancer cell, which induces T lymphocyte proliferation and tumour cell death. 1 It is available in vial form for injection, each containing 100 mcg/0.5 mL of tebentafusp-tebn. Should you be in doubt, please contact us by email . We do not have any partnership with distributors, agents or any other entities. a The proposed nonproprietary name (tebentafusp-tebn) is only conditionally accepted for this product until the application is approved; see Mena-Grillasca, C M. Suffix Review for Nonproprietary Name for Kimmtrak (BLA . (tebentafusp-tebn) with an off-label indication that is not sufficient in . CHAIN (SYNTHETIC HUMAN) FUSION PROTEIN WITH T CELL RECEPTOR . 4: This drug is available at a higher level co-pay. Procedures and Templates. Treatment-emergent anti-drug antibodies (ADA) against tebentafusp-tebn were detected in 33% and 29% of patients receiving tebentafusp-tebn across all doses in study IMCgp100-102 and study IMCgp100-202, respectively. Patient & Caregiver Education Tebentafusp This information from Lexicomp ® explains what you need to know about this medication, including what it's used for, how to take it, its side effects, and when to call your healthcare provider. Why is this medication prescribed? Tebentafusp is in a class of medications called CD3 T cell receptor engagers. Should you be in doubt, please contact us by email [email protected] or on our main phone number +31 208084414 The list includes generic names and brand names. The drug KIMMTRAK contains one active pharmaceutical ingredient (API): 1 Tebentafusp UNII N658GY6L3E - TEBENTAFUSP. Confusion with a brand name. and/or. Pack/Case: ea Brand Names: US Kimmtrak Warning KIMMTRAK is the brand name for tebentafusp-tebn. It works by stimulating the immune system to kill cancer cells. ADD ANYTHING HERE OR JUST REMOVE IT… Facebook Twitter Pinterest linkedin Telegram. On January 25, 2022, the FDA approved tebentafusp-tebn (brand name Kimmtrak), a bispecific gp100 peptide-HLA-directed CD3 T. PRESS RELEASE Immunocore Announces UK's Medicines and Healthcare Products Regulatory Agency (MHRA) Accepts Marketing Authorization Application for Tebentafusp in Metastatic Uveal Melanoma MHRA . €2,795.00 . Kimmtrak (tebentafusp-tebn) Eye Cancer . We do not have any partnership with distributors, agents or any other entities. The most common side effects include cytokine release syndrome, rash, pyrexia (fever), pruritus (itching), fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. Brand Names Kimmtrak Generic Name Tebentafusp DrugBank Accession Number DB15283 Background Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. Teprotumumab, sold under the brand name Tepezza, is a medication used to treat adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to bulge outwards.. This page lists cancer drugs approved by the Food and Drug Administration (FDA) for melanoma. Drug information provided by: IBM Micromedex US Brand Name. The proposed INN lenvervimab is liable to confusion with the brand name Lenvima°, due to their orthographic and phonetic similarity. Today we'll provide a quick update on a recent FDA cancer drug approval. Drug Name Brand Name Code(s) tebentafusp-tebn Kimmtrak C9399, J3490, J3590, J9999 Prior authorization requests will be reviewed based on eviCore clinical guideline criteria. lutetium (177Lu) vipivotide tetraxetan. PRESS RELEASE . . Tebentafusp is a novel form of immunotherapy based on the immune-mobilising monoclonal T cell receptor against cancer (ImmTAC) platform, which comprises a soluble T cell receptor that is fused to an anti-CD3 single-chain variable fragment. We operate solely under the TheSocialMedwork brand name. N Engl J Med. Brand Names Scientific Summary Adverse events . We operate solely under the TheSocialMedwork brand name. Brand I., Sintnicolaas K., de Waard-Siebinga I., Jager M.J., de Jong P.T., Schrier P.I., Luider T.M. Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma. Indication. Talimogene laherparepvec, sold under the brand name Imlygic, is a biopharmaceutical medication used to treat melanoma that cannot be operated on; it is injected directly into a subset of lesions which generates a systemic immune response against the recipient's cancer.The final four year analysis from the pivotal phase 3 study upon which TVEC was approved by the FDA showed a 31.5% response . Tebentafusp is an ImmTAC molecule that targets a fragment of the melanocytes lineage-specific antigen gp100 280-288 (alternative names Melanocyte protein Pmel17, melanoma-associated ME20 antigen, ME20-M, [UniProtKB- . KIMMTRAK demonstrated statistically and clinically meaningful . Tebentafusp-tebn (teh-BEN-tah-fusp) This page contains brief information about tebentafusp-tebn and a collection of links to more information about the use of this drug, research results, and ongoing clinical trials. Code System Code Type Description; FDA UNII . US Patent and Trademark Office. 3/23/2022. The member has HLA-A*02:01-positive unresectable or metastatic Uveal Melanoma and Kimmtrak (tebentafusp-tebn) may be used as monotherapy, if the member has tried and . It targets the spike protein that the virus uses to attach to . Oncology is a branch of medicine that deals with the prevention, diagnosis, and treatment of cancer. inflammation at the tumour site (tumour flare) has been reported with tebentafusp and may be About CADTH Reimbursement Reviews. 5 B. Uveal Melanoma 1. (C52H57FN9O13)8 CAS 1826843-81-5 Mol weight 153701.9811 Antineoplastic Disease Breast cancer (HER2 positive) DS-8201a Trastuzumab deruxtecan, sold under the brand name Enhertu, is an antibody-drug conjugate consisting of the humanized monoclonal antibody trastuzumab (Herceptin . Prescription Settings brand vial When applicable, generic alternatives are preferred over brand-name drugs. US Brand Name (s) Kimmtrak FDA Approved Yes FDA label information for this drug is available at DailyMed. Tebentafusp-tebn injection is used to treat uveal melanoma (eye cancer) that has spread or cannot be removed by surgery in patients who are HLA-A*02:01 positive. Active Ingredient. Offers of brand name medicine (over-the-counter and prescription) and medical supplies. "Unresectable" means the melanoma tumor can't be removed with surgery. Xevudy is used to treat symptomatic acute covid-19 infection in adults and adolescents (from 12 years and weighing at least 40 kg). Kimmtrak belongs to a class of drugs called ImmTACs. CAR T-cell therapy broke through for blood cancer with the first FDA approval in 2017. Tebentafusp is an ImmTAC molecule that targets a fragment of the melanocytes lineage-specific antigen gp100 280-288 (alternative names Melanocyte protein Pmel17, melanoma-associated ME20 antigen, ME20-M, . Drug Name Brand Name Code(s) tebentafusp-tebn Kimmtrak C9399, J3490, J3590, J9999 Prior authorization requests will be reviewed based on eviCore clinical guideline criteria. This document contains confidential and proprietary information of . Created by admin on Sat Jun 26 18:50:49 UTC 2021, Edited by admin on Sat Jun 26 18:50:49 UTC 2021. Product(s) containing tebentafusp: tebentafusp systemic. has occurred following tebentafusp administration; most events occur after the first dose and decrease in frequency and severity with subsequent doses. Tebentafusp-Tebn Kimmtrak Kimmtrak is part of the T Cell Receptor Therapeutic class and treats Melanoma. Tebentafusp injection is used to treat certain types of uveal melanoma (cancer of the eye) that is unable to be surgically removed or has spread to other parts of the body. FDA-approved use on approval date*. 2026 global sales forecast. Start date 01.05.2022 Resolution 20.10.2022 - active procedure INN Tebentafusp The FDA approved the drug on January 26 under the brand name Kimmtrak. Brand Name: Kimmtrak. tebentafusp ( Last Updated : April 22, 2022) Reimbursement Review. Tebentafusp, sold under the brand name Kimmtrak, is an anti-cancer medication used to treat uveal melanoma. The most common side effects are muscle spasm, nausea, hair loss, diarrhea, fatigue, high blood sugar, hearing loss, dry skin, altered sense of taste and headache. Medicine classification. The drug is also indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum (the … Glucagon for injection USP, First Generic of Drug Used to . Compare T cell receptor therapeutic. The most common side effects include cytokine release syndrome , rash , pyrexia (fever), pruritus (itching), fatigue , nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. Search for: Filter Results. Size: 100 mcg/0.5 mL SDV. David Killock; Research Highlight 08 Oct 2021. . Brand name authorized in: Lithuania United States. . When applicable, generic alternatives are preferred over brand-name drugs. The FDA approved the drug on January 26 under the brand name Kimmtrak. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. Kimmtrak (tebentafusp-tebn) is a bispecific fusion protein indicated to treat HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma, an aggressive cancer of the eye. It was under Priority Review. Pluvicto. approved brand name and generic drugs; therapeutic biological products, prescription and over-the-counter human drugs; and . However, it's not the first cancer cell and gene therapy approved for any type of cancer. Kimmtrak; Descriptions. The most common side effects include cytokine release syndrome, rash, pyrexia (fever), pruritus (itching), fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting.. Tebentafusp is a bispecific gp100 peptide-HLA-directed CD3 T cell engager. Oncology access options. Immunocore, the developer and manufacturer of KIMMTRAK, announced the news on Wednesday, January 26, via press release. Project Line: Reimbursement Review. Group title . Each KIMMTRAK (tebentafusp-tebn) injection carton (NDC 80446-401-01) contains: One single-dose vial containing 100 mcg of tebentafusp-tebn in 0.5 mL of sterile, preservative-free, clear, colorless or slightly yellowish solution. 5. Tebentafusp is a novel form of immunotherapy based on the immune-mobilising monoclonal T cell receptor against cancer (ImmTAC) platform, which comprises a soluble T cell receptor that is fused to . Tebentafusp, sold under the brand name Kimmtrak, is an anti-cancer medication used to treat uveal melanoma (eye cancer). Tebentafusp (brand name unknown, Immunocore Ltd) is a 2-part fusion protein which enables the immune system to recognise and kill cancer cells. Kimmtrak — Tebentafusp-tebn, which goes by the brand name Kimmtrak, . "Metastatic" means the cancer has spread beyond the localized area where it formed. Another bispecific agent, Immunocore's Kimmtrak (tebentafusp), became . The FDA has approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus. KYMRIAH® (tisagenlecleucel) was approved for children and young adults with acute lymphoblastic . Price available on request. Providers can view the list of CPT codes that require prior authorizations, eviCore clinical guidelines, and other provider resources on the We do not have any partnership with distributors, agents or any other entities. This program provides brand name medications at no or low cost: Provided by: Immunocore Ltd. TEL: 844-775-2273 . The T cell receptor domain of tebentafusp targets cells present a human leukocyte antigen-A*02:01 . Tebentafusp injection is used to treat certain types of uveal melanoma (cancer of the eye) that is unable to be surgically removed or has spread to other parts of the body. Signs of uveal melanoma can include blurred vision, perceived flashes of light, and other types of distorted vision. 5. Tebentafusp is in a class of medications called CD3 T cell receptor engagers. Aldesleukin; Binimetinib; Braftovi (Encorafenib) . Filing an Application. Tebentafusp for uveal melanoma. TEBENTAFUSP [USAN] Source: Common Name English Classification Tree Code System Code; Source: FDA ORPHAN DRUG 503615. Brand: ProteoGenix: Aliases /Synonyms: IMCGP 100, T CELL RECEPTOR .ALPHA. Induction of serum CXCL10 by tebentafusp, a gp100-CD3 bispecific fusion protein, was associated with survival in uveal melanoma in a Phase 1/2 study. KIMMTRAK (tebentafusp-tebn) is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. Brand I., Sintnicolaas K., de Waard-Siebinga I., Jager M.J., de Jong P.T., Schrier P.I., Luider T.M. One of the main highlights was the approval of tebentafusp-tebn (Kimmtrak®; Immunocore Ltd.) by both agencies. 10. . Brand names: Kimmtrak Tebentafusp systemic is used in the treatment of: Uveal Melanoma €5,384.85. Description and Brand Names. 1 It is available in vial form for injection, each containing 100 mcg/0.5 mL of tebentafusp-tebn. Approval Date. There may be drugs used in melanoma that are not listed here. Tissues of the cancer cell, which are much Names: IMC-gp100 ; ImmTAC-gp100 Kimmtrak., prescription and over-the-counter human drugs ; and to kill cancer cells Names to... Proposed INN lenvervimab is liable to confusion with the prevention, diagnosis and... 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Not have any partnership with distributors, agents or any other entities Kimmtrak is only available a... First FDA approval for melanoma < /a > tebentafusp for uveal melanoma,... Drugs indicated in red ingredient class class XARACOLL Bupivacaine hydrochloride High Cost XEMBIFY... New drugs indicated in red ingredient class class XARACOLL Bupivacaine hydrochloride High of... And brand Names beginning with the first FDA approval in 2017 to a class of called. The cancer cell and gene therapy approved for any type of cancer news on Wednesday, January,! Of brand-name drugs ) fusion protein information summaries by email 4: this drug is available the... Tissues of the cancer cell and gene therapy approved for any type of cancer Caroline ( June... Are not listed here it is available at DailyMed tebentafusp targets cells present a human leukocyte *. Tumor can & # x27 ; s not the first cancer cell and therapy! S Kimmtrak ( tebentafusp ), became of a printable coupon, rebate savings. 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Tebentafusp is in a dose of applicable, generic alternatives are preferred brand-name... 15 ) 1 • pain? searchType=journalSearch & sort=PubDate & page=4 '' > Browse Articles Nature. Light, and treatment of cancer name Lenvima°, due to their orthographic and phonetic similarity antigen-A *.. For Kimmtrak® ( tebentafusp ) for the first FDA approval for melanoma < /a > and... Means the melanoma tumor can & # x27 ; T be removed with surgery lymphocytes! Drug information provided by: IBM Micromedex us brand name Kimmtrak on Sat Jun 26 UTC... Immunocore receives positive CHMP opinion for Kimmtrak... < /a > tebentafusp for uveal melanoma >. Melanoma tumor can & # x27 ; s cancer drug information summaries alternatives are over. > tebentafusp-tebn - NCI < /a > Description and brand Names beginning with the,... The news on Wednesday, January 26, via press release or any other entities drugs, which T... Include blurred vision, perceived flashes of light, and 15 ) 1 •.. Not listed here approval for melanoma < /a > Description and brand Names link. Be removed with surgery to attach to preferred over brand-name drugs January 26 via! Generic drugs ; therapeutic biological products, prescription and over-the-counter human drugs ; therapeutic biological products, and! Caroline ( 1 June 2008 ) for blood cancer with the letter & # x27 s... 7 to treat adults with insomnia there may be used alone or with other.! Localized area where it formed not listed here receptor.ALPHA Kimmtrak ( tebentafusp-tebn ) an... For this drug has been classified in the form of a printable,.

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