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Imlygic Approval History

  • FDA approved: Yes (First approved October 27th, 2015)
  • Brand name: Imlygic
  • Generic name: talimogene laherparepvec
  • Dosage form: Injection
  • Company: Amgen Inc.
  • Treatment for: Melanoma

Imlygic (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the local treatment of melanoma lesions in the skin and lymph nodes.

FDA Approval: The safety and efficacy of Imlygic were evaluated in a multicenter study of 436 patients with metastatic melanoma that could not be surgically removed. In studies, 16.3 percent of those who received Imlygic had a decrease in the size of lesions, lasting at least six months, compared to 2.1 percent of participants who received the comparator therapy. Imlygic has not been shown to improve overall survival or to have an effect on melanoma that has spread to other organs.

Mechanism: Imlygic is a genetically modified live oncolytic herpes virus therapy injected directly into melanoma lesions, where it replicates inside cancer cells and causes the cells to rupture and die. The exact mechanism of action of Imlygic is unknown.

Dosage: A course of Imlygic consists of a series of injections into the melanoma lesions. After the initial injection, a second dose is administered three weeks later, followed by additional doses every two weeks for at least six months unless other treatment is required or until there are no injectable lesions to treat.

Side Effects: The most common side effects observed in clinical study participants were fatigue, chills, fever, nausea, flu-like symptoms and pain at the injection site.

Additional Patient Information: Patients and close contacts should avoid direct contact with the injection site to prevent viral transmission of the herpes virus. Female patients of childbearing potential should use an effective method of contraception to prevent pregnancy during treatment.

Development History and FDA Approval Process for Imlygic

Oct 27, 2015Approval FDA Approves Imlygic (talimogene laherparepvec) for the Treatment of Melanoma
May 26, 2015Pivotal Study Results Showed Talimogene Laherparepvec Improved Durable Response Rates in Patients With Metastatic Melanoma
Apr 29, 2015Amgen to Discuss Details of BLA for Talimogene Laherparepvec for Patients with Metastatic Melanoma
Feb 11, 2015Amgen Announces FDA Advisory Committees to Review Talimogene Laherparepvec for the Treatment of Patients with Metastatic Melanoma
Jun  3, 2013Amgen Presents Positive Results From Talimogene Laherparepvec Phase 3 Study In Patients With Metastatic Melanoma
Mar 20, 2013Amgen Announces Top-Line Results Of Phase 3 Talimogene Laherparepvec Trial In Melanoma

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