Amgen's T-Vec wins FDA nod, EU committee recommendation

In the last week, Amgen received regulatory endorsements on each side of the Atlantic for its first-in-class oncolytic viral therapy talimogene laherparepvec, known as T-Vec.

On Tuesday, the dual-acting cancer vaccine/viral therapy won its expected FDA approval for inoperable melanoma recurrent after initial surgery; it'll be sold by Amgen ($AMGN) as Imlygic at an average price of $65,000. The approval follows an April vote by an FDA advisory panel of 22 to 1 in favor of recommending the anticancer treatment.

The FDA's blessing for Imlygic comes one week after an EU committee recommended the drug, likely putting it months away from approval in Europe.

In its Phase III trial dubbed OPTiM, T-Vec showed a "significantly higher" durable response rate compared with patients who received granulocyte-macrophage colony-stimulating factor (GM-CSF), meeting its primary endpoint. However, it missed its secondary endpoint of overall survival. To achieve that, the company said in a statement, Imlygic uses a genetically modified herpes simplex virus fashioned to replicate in tumors and produce GM-CSF. The cell lysis ruptures tumors and releases tumor-derived antigens, which may create an antitumor response in conjunction with GM-CSF, the company said. However, Amgen admits that "the exact mechanism of action is unknown."

Back in April, just two days before the FDA's committee was set to consider the therapy, agency staffers recommended against accelerated approval for the candidate, pointing to concerns with the trial and a possible investigator bias. However, in recommending T-Vec, the panel cited its ability to give healthcare providers another "arrow in the quiver" to manage the cancer that caused 9,710 deaths last year.

Amgen R&D head Sean Harper on Tuesday touted that attribute from T-Vec.

Amgen R&D head Sean Harper

"Not all melanoma patients currently benefit from available therapies, and Imlygic represents an important new option that can provide meaningful durable responses for patients with this aggressive and complex disease," he said.

Though Tuesday's FDA approval covered T-Vec as a monotherapy, Amgen has partnered with Bristol-Myers Squibb ($BMY) and Merck ($MRK) to test it in combination with their respective immunotherapies.

T-Vec's advancements come amid a wave of action in the cancer vaccines space that has seen its fair share of troubles through the years, notably Provenge-maker Dendreon's bankruptcy and two late stage failures last year from GlaxoSmithKline ($GSK) and Merck KGaA. Within the last month, four companies have launched to develop personalized cancer vaccines: Neon Therapeutics, Gritstone Oncology, Caperna and Turnstone Biologics. Prior to that, several multinational pharmaceuticals struck collaboration deals with cancer vaccine developers to seek out the benefits of cancer vaccines paired with their own therapies. AstraZeneca's ($AZN) MedImmune partnered with Inovio ($INO) to gain access to its HPV cancer vaccine in a deal potentially worth $727 million, Johnson & Johnson ($JNJ) signed on with Aduro ($ADRO) in a GVAX pact worth up to $1 billion and Bristol-Myers Squibb paired with Bavarian Nordic on Prostvac, also a deal potentially worth $1 billion.

One recent report pegged the field to grow at a CAGR of 27.24% through 2019.

- here's the release

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