|Amgen R&D chief Dr. Sean Harper|
Back in June, Amgen ($AMGN) said it was eyeing a U.S. application for its cancer-fighting viral vaccine in the short term but would be looking outside the U.S. as well. Look no further: After submitting its candidate to the FDA in July, the company now says it's turned over a marketing authorization application to the European Medicines Agency for the melanoma candidate.
Amgen is seeking approval for the jab--dubbed talimogene laherparepvec, or T-Vec for short--in patients with regionally or distantly metastatic forms of the skin cancer, the California drugmaker said Tuesday. If approved, the oncolytic vaccine--designed to kick-start an antitumor immune response in patients--will be the first in its class of oncolytic immunotherapies in the EU.
The submission "brings us a step closer to helping address an unmet medical need for patients with metastatic melanoma," Amgen R&D chief Dr. Sean Harper said in a statement. "This regulatory milestone, on the heels of our Biologics License Application submission to the U.S. FDA, represents an important step for our pipeline."
Amgen based its filing on Phase III trial results it announced back in April. In that study, T-Vec hit its primary endpoint with a 16% durable response rate and increased the median overall survival rate to 4.4 months. But there was one blip: That OS rate fell just short of statistical significance.
That wasn't enough to deter the Thousand Oaks-based biotech from heading down the regulatory pathway, however, and now it's going where only Dendreon ($DNDN) has gone before with a cancer vaccine. But despite Dendreon's FDA and EMA nods for its prostate cancer therapeutic, Provenge, marketing and manufacturing challenges dragged the Seattle company down, suggesting that Amgen's biggest challenges with T-Vec may come on the other side of regulatory approval.
- read Amgen's release
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