UPDATED: Amgen wins quick EU approval for Imlygic, its first-in-class immuno-oncology drug

Amgen ($AMGN) is building momentum for its new first-of-its-kind cancer fighter, Imlygic. Two months after getting FDA approval for treating deadly melanoma, it has done the same in Europe, making Imlygic the first immunotherapy oncology drug approved there.

The Thousand Oaks, CA-based company said today that the European Commission had approved Imlygic to treat inoperable melanoma that has spread, except for those patients whose cancer has spread to the brain, bone, lungs and gut. 

The injection uses a genetically modified strain of the herpes virus, the so-called cold sore virus, to invade tumors and replicate itself, killing cancer and spurring an immune response to multiply its effect. Injecting Imlygic into melanoma lesions shrank tumors at a statistically significant rate in its Phase III trial.

Amgen R&D chief Sean Harper

"As the first oncolytic immunotherapy authorized in the European Union, the approval of Imlygic is an important milestone for this new class of drugs, bringing patients with a rare and deadly form of skin cancer a much needed new treatment option," Sean Harper, Amgen's head of R&D, said today in a statement.

The company will now go through the process of negotiating prices with each of the 31 countries that adhere to EC approvals. In the U.S., Amgen has said the drug will average $65,000 per patient, but with the caveat that differences in dosing for each patient makes that a ballpark number only.

Amgen bought the treatment in 2011 when it struck a $1 billion deal for BioVex. While initially approved for use against melanoma, the bet is that it also will be effective as a combo therapy against other cancers, a strategy makers of other immunotherapies are following. Amgen is already working to combo Imlygic with Merck's ($MRK) PD-1-blocking Keytruda in melanoma and head and neck cancer. It also has a collaboration with Roche ($RHHBY) to see how Imlygic works in breast and colon cancers when paired with Roche's PD-L1 immuno-oncology candidate.

It is Amgen's second win in recent weeks with the EC. In November, it got approval for Kyprolis when used in combo with Celgene's ($CELG) Revlimid and dexamethasone for treating adult multiple myeloma sufferers who have already received at least one other therapy. That win, however, came more than three years after the drug's approval in the U.S.

- here's Amgen's announcement

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