Amgen's first-in-class oncolytic drug wins FDA approval with combo studies on deck

Amgen ($AMGN) won a landmark approval for a re-engineered virus designed to fight skin cancer, preparing to launch a first-of-its-kind therapy that could star in future combination treatments.

The injection, called talimogene laherparepvec, is a so-called oncolytic immunotherapy, using a genetically modified strain of the herpes virus to invade tumors and replicate itself, thereby killing cancer and spurring an immune response to multiply its effect. Abbreviated T-Vec, the treatment is approved for inoperable melanoma that has already endured first-line therapy, and Amgen plans to launch it within a week under the brand name Imlygic.

In the Phase III trial supporting its approval, injecting T-Vec into melanoma lesions shrank tumors at a statistically significant rate, meeting the primary endpoint of the study, but Amgen's treatment fell narrowly short of hitting its secondary goal of extending overall survival. The mixed results haven't hampered Amgen's case to regulators, however, and Imlygic is in line for European approval by year's end.

Amgen expects the drug to cost an average of $65,000 per patient, saying the variability of dosing for each person makes it difficult to nail down an exact price.

As is the case for all cancer immunotherapies, Imlygic's most promising future may lie as part of a combination therapy. Recognizing its potential, Amgen is collaborating with Merck ($MRK) on a study pairing its treatment with the PD-1-blocking Keytruda in melanoma and head and neck cancer. And Roche ($RHHBY) has signed on to match its atezolizumab, a PD-L1 therapy, with T-Vec in breast and colon cancers.

Amgen acquired the treatment in 2011 in its $1 billion deal for 2009 Fierce 15 honoree BioVex.

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