What is IMLYGIC used for?
IMLYGIC® (talimogene laherparepvec) is a prescription medication used to treat a type of skin cancer called melanoma when it is on your skin or in your lymph glands. IMLYGIC® may not help you live longer and may not shrink cancer in your organs (for example, lung or liver).
How is IMLYGIC administered?
Administer IMLYGIC by injection into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable, or detectable by ultrasound guidance.
Is IMLYGIC a biologic?
27, 2015 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has approved the Biologics License Application for IMLYGIC™ (talimogene laherparepvec), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous.
When was IMLYGIC approved?
Development timeline for Imlygic
| Date | Article |
|---|---|
| Oct 27, 2015 | Approval FDA Approves Imlygic (talimogene laherparepvec) for the Treatment of Melanoma |
Is Imlygic a gene therapy?
Imlygic is a type of advanced therapy medicine called a ‘gene therapy product’. This is a type of medicine that works by delivering genes into the cells of the body. It contains the active substance talimogene laherparepvec.
How do you say Imlygic?
IMLYGIC® (pronounced “Im•LIE•jik”) is used to treat unresectable melanoma in the skin or lymph glands.
What are the side effects of Tvec injections?
They include: cancerous white blood cells near or at the injection site (plasmacytoma) an allergic reaction – you may get a rash, shortness of breath, redness or swelling of the face. herpes eye infection (keratitis herpes)
What drugs are considered gene therapy?
(A) In vivo approved gene therapy drugs such as Neovasculgen, Glybera, Defitelio, Rexin-G, Onpattro, Eteplirsen, Spinraza, Kynamro, Imlygic, Oncorine, Luxturna, Macugen, Gendicine, Vitravene as well as Zolgensma directly injected into their target tissue or organ.
Is Chemo an Imlygic?
Immunotherapy is cancer treatment that directly kills cancer cells and stimulates the body’s immune system to fight cancer, such as melanoma. Imlygic (talimogene laherparepvec, or T-VEC) is a local immunotherapy treatment that kills melanoma cells in the skin and lymph nodes.
What is T-VEC for melanoma?
T-VEC is the first genetically modified herpes simplex virus-1-based oncolytic immunotherapy approved by FDA and EMA for the treatment of unresectable, cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery [72,73].
How effective is Imlygic?
On average, patients taking IMLYGIC® could see a response by 4.1 months. 1. Some people began to respond to treatment as early as 1.2 months, and others as late as 16.7 months.
What does T-VEC stand for?
Talimogene laherperepvec (T-VEC) is an injectable modified oncolytic herpes virus being developed for intratumoral injection, that produces granulocyte-macrophage colony-stimulating factor (GM-CSF) and enhances local and systemic antitumor immune responses.
What are the four approaches of gene therapy?
Putting the Human Genome to Work: Using Genes to Treat Disease
- Gene-transfer approaches, in which a wild-type copy of the mutated gene is delivered.
- RNA modification therapy, in which the mRNA encoded by a mutant gene is targeted.
- Stem cell therapy, in which human stem cells are used to repair disease-damaged tissue.
Is T-VEC a vaccine?
Amgen ($AMGN) has stepped up with a new round of late-stage data supporting its cancer-fighting viral vaccine talimogene laherparepvec, better known as T-Vec.
What is Imlygic used to treat?
Indication and Limitations of use. IMLYGIC® (talimogene laherparepvec) is a prescription medication injected on the skin, beneath the skin, or in your lymph glands to treat a type of skin cancer called melanoma when it can no longer be surgically removed.
What are the contraindications for Imlygic ®?
Contraindications. Do not administer IMLYGIC ® to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy, due to the risk of life-threatening…
Is Imlygic FDA approved for melanoma?
IMLYGIC ® (talimogene laherparepvec) Prescribing Information, BioVex Inc., a subsidiary of Amgen Inc. FDA approves first oncolytic virus therapy: Imlygic for melanoma. Oncology Times. 2015;37:36. doi:10.1097/01.COT.0000475724.97729.9e. Data on file. Amgen; 2015.
Is Imlygic available in the European Union?
The European Commission granted a marketing authorisation valid throughout the European Union for Imlygic on 16 December 2015. For more information about treatment with Imlygic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Please note that the size of the above document can exceed 50 pages.