Amgen Inc. (NASDAQ: AMGN) is slowly getting closer to an U.S. Food and Drug Administration (FDA) final decision for its first-of-a-kind cancer therapy, talimogene laherparepvec (T-Vec). The final decision will be handed down by the FDA on October 27, with a likely European approval coming in the next few months.

Back in April, a U.S. panel of independent agency advisors voted 22 to one in favor of approving this treatment.

The company’s T-Vec is a so-called oncolytic immunotherapy, using a genetically modified strain of the herpes virus to invade tumors and replicate itself, killing cancer cells along the way and spurring an immune response to double its effect.

In a Phase 3 trial, injecting T-Vec into melanoma lesions had a statistically significant effect on durable response rate, the primary endpoint of the study, but this treatment fell just short of its secondary goal of overall survival.

Despite these mixed results, regulators are still positive on T-Vec. The European Medicines Agency’s scientific committee has now recommended approval for the injection as a treatment for advanced melanoma in which surgery is not an option. Such recommendations are usually followed by full approval within three months, and Amgen is planning to market its therapy as Imlygic.

If T-Vec should win approval around the globe, Amgen’s next obstacle will be to demonstrate that the viral treatment can work along with immunotherapies already on the market. Amgen is already collaborating with Merck on a study pairing the PD-1-blocking Keytruda with T-Vec in melanoma and head and neck cancer. Roche has also signed on to match its atezolizumab, a PD-L1 therapy, with T-Vec in breast and colon cancers.

Shares of Amgen were last seen on Friday up 1.5% at $154.62. The consensus analyst price target is $184.83, and the 52-week trading range is $130.09 to $181.81.

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