FDA to Review Treatment Injected into Metastatic Melanoma Tumors

The gist: A treatment for metastatic melanoma called talimogene laherparepvec (T-VEC) will soon be reviewed by the FDA for treating patients with metastatic melanoma. If T-VEC is approved, doctors in the U.S. will be free to prescribe it to their patients. T-VEC is an immune system-boosting treatment that is injected directly into melanoma tumors. Learn more about it in this Need to Know blog post.

“Amgen (NASDAQ: AMGN) announced today that the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) will jointly review the Company’s Biologics License Application (BLA) for talimogene laherparepvec. The FDA is currently reviewing the talimogene laherparepvec BLA for the treatment of patients with injectable regionally or distantly metastatic melanoma. The advisory committees will review talimogene laherparepvec at a meeting on April 29, 2015.

” ‘The incidence of melanoma has continued to rise in recent years, and even with recent additional options in treatment, there is an important unmet medical need,’ said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. ‘We look forward to discussing the efficacy and safety profile of talimogene laherparepvec with the advisory committees, and we are committed to working closely with the FDA during its review of the BLA.’ “


Advanced Melanoma: The Promise and Shortcomings of Drugs Injected Directly into Tumors


In the past 3 years, the treatment landscape for metastatic melanoma has changed dramatically. We saw the advent of drugs that inhibit mutant BRAF and activate MEK proteins (vemurafenib, dabrafenib, and trametinib) and drugs known as immune checkpoint inhibitors (ipilimumab, Keytruda, Opdivo, and others). These treatments are ‘systemic’; that is, they are taken by mouth or injected directly into the bloodstream and spread throughout the body. However, as I reported earlier this year, drugs that are injected directly into tumors—’intralesional drugs’—have recently gained some attention. Two of them were featured at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting. New data, and doubts, on these drugs have since emerged. Continue reading…


UPDATE 1-Amgen Melanoma Drug Fails to Improve Overall Survival Rates

“Amgen Inc said its experimental drug to treat a deadly form of skin cancer did not significantly improve overall survival rates in patients enrolled in a late-stage study.

“The company said the drug met the study’s main goal of shrinking tumors, as it had previously reported, but did not meet the secondary goal of improving overall survival in patients with melanoma.”

Editor’s note: Earlier results from this trial showed that the drug (called T-Vec) improved “progression free survival,” which refers to the length of time before a patient’s tumor begins growing again. Now, T-Vec has been shown not to affect overall survival times.


Amgen Vaccine Triggers Immune Response in Advanced Melanoma -Study

“An experimental Amgen Inc cancer vaccine used to treat advanced melanoma, the deadliest form of skin cancer, proved effective in a late-stage study in shrinking tumors in a way that suggests the drug triggered the intended systemic immune response, according to data presented on Friday.

“The vaccine shrank tumors that were directly injected with the drug and tumors around the body that were not injected, according to the data.

“The drug, talimogene laherparepvec, also known as T-vec, is an engineered virus designed to replicate inside the injected tumor, killing cancer cells there, as well as prime the immune system to attack other cancer cells around body.”


Genetically Modified Cold Sore Virus Shows Promise in Melanoma


A new immunotherapy known as talimogene laherparepvec (T-VEC), or Ovcovex GM-CSF, has shown the ability to shrink advanced melanoma tumors. T-VEC is a genetically modified version of herpes simplex virus type 1, the virus that causes cold sores. T-VEC was also engineered to produce GM-CSF (granulocyte-macrophage colony-stimulating factor), a protein that stimulates the immune system.  Amgen, the California-based biopharmaceutical company that is developing the experimental cancer therapy, announced on March 19 that T-VEC had shown positive results in an advanced melanoma clinical trial. Continue reading…


Melanoma Drug Succeeds in Late-Stage Trial

“A cancer drug based on a tumor-killing virus has for the first time succeeded in a late-stage clinical trial, giving a lift to a technology that has long tantalized doctors and researchers. Amgen, which is developing the drug, said late Tuesday that it had met the primary goal of a Phase 3 clinical trial in patients with advanced melanoma, the deadliest type of skin cancer.”