Amgen ($AMGN) is now months away from a likely European approval with a first-of-its-kind cancer therapy, securing a positive opinion from a key regulatory group.
The company's talimogene laherparepvec, or T-Vec, is a so-called oncolytic immunotherapy, using a genetically modified strain of the herpes virus to invade tumors and replicate itself, killing cancer cells along the way and spurring an immune response to double its effect. In a Phase III trial, injecting T-Vec into melanoma lesions had a statistically significant effect on durable response rate, the primary endpoint of the study, but Amgen's treatment fell just short of its secondary goal of overall survival.
T-Vec's mixed results are yet to hold it back with regulators, however, and the European Medicines Agency's scientific committee has now recommended approval for the injection as a treatment for advanced melanoma in which surgery is not an option. Such recommendations are usually followed by full approval within three months, and Amgen is planning to market its therapy as Imlygic.
In the U.S., the FDA has promised to hand down a final decision on T-Vec by Oct. 27. In April, a panel of independent agency advisers voted 22-1 in favor of approving the treatment.
If T-Vec wins approval around the globe, Amgen's next task is demonstrating that the viral treatment can work hand in hand with immunotherapies already on the market. The company is collaborating with Merck ($MRK) on a study pairing the PD-1-blocking Keytruda with T-Vec 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 picked up T-Vec in its $1 billion deal for 2009 Fierce 15 honoree BioVex.
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