Amgen's Virus-based Cancer Treatment Awaits FDA's Final Word

Amgen FDA 102715

After a not-so smooth sailing at panel review - though all but one of the 23 members voted in favor of approval - Amgen Inc.'s (AMGN) virus-based cancer treatment IMLYGIC for melanoma now awaits the FDA's final decision.

IMLYGIC, or talimogene laherparepvec, is a genetically modified herpes simplex type 1 virus that is injected directly into tumors. It works in 2 ways. First, it replicates inside the tumor's cells causing the cell to rupture and die in a process called lysis. Second, the rupture of the cancer cells causes the release of tumor-derived antigens, which together with virally derived granulocyte-macrophage colony-stimulating factor (GM-CSF) may help to promote an anti-tumor immune response.

Initially developed by privately-held BioVex Inc. under the name OncoVex GM-CSF, IMLYGIC came under Amgen's fold in 2011, when BioVex was acquired by Amgen for nearly $1 billion.

IMLYGIC monotherapy is the first oncolytic immunotherapy to demonstrate therapeutic benefit in a phase III pivotal trial for patients with metastatic melanoma.

In the phase III trial, dubbed OPTiM, which compared IMLYGIC to GM-CSF in patients with advanced melanoma, 16.3% of patients treated with IMLYGIC achieved a complete response or partial response within the first 12 months of treatment and maintained it continuously for at least six months compared to 2.1% of patients treated with GM-CSF. The median overall survival was 4.4 months longer in the IMLYGIC arm than in the GM-CSF arm.

The FDA's original decision date on IMLYGIC was scheduled for July 28, 2015. But, in February of this year, the company announced that the BLA for IMLYGIC was to be reviewed by an advisory committee on April 29, 2015 before the FDA males its final decision. So the FDA's decision date was postponed to October 27, 2015.

On April 29, 2015, a panel for the FDA voted 22 to 1 to approve IMLYGIC for patients with metastatic melanoma. The FDA typically follows the recommendations of its advisory panels, although it is not bound to do so.

Will IMLYGIC get the final stamp of approval from FDA? Stay tuned...

Meanwhile, last week, the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, adopted a positive opinion recommending that IMLYGIC be granted approval for the treatment of adults with advanced melanoma. A final decision of the European Commission is expected in the coming months.

AMGN closed Monday's trading at $158.58, up 1.82%.

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