Amgen wins FDA panel nod for T-Vec in melanoma

– Wednesday’s vote came just two days after FDA staff reviewers recommended against accelerated approval for the candidate, citing concerns with the trial method and outcomes, specifically the possibility for investigator bias.

– The former jab failed to reach endpoints for non-small cell lung cancer and previously failed to outperform placebo in a melanoma trial

April 29, 2015 | By Eric Sagonowsky

FDA staffers had their doubts this week heading into an advisory committee meeting on Amgen’s ($AMGN) dual-acting cancer vaccine/viral therapy, talimogene laherparepvec (T-Vec). But Wednesday afternoon, a combined FDA advisory panel voted overwhelmingly in favor of the candidate.

The committee voted 22 to 1 that the prospect boasts a favorable risk/benefit profile for melanoma patients, citing the therapy’s capability to give physicians another “arrow in the quiver” to manage the cancer.

T-Vec, an oncolytic immunotherapy, is engineered to cause cell lysis by replicating in tumors, thus activating an antitumor immune response. In the decision, advisers cited minimal risks and the desire to give certain subpopulations another option for treating the cancer that caused 9,710 deaths last year.

“To patients who are at late stage, of any cancer, anything you can do to provide them with some hope and encouragement is going to give them a lot more benefit than just medical treatment,” one reviewer said.

Wednesday’s vote came just two days after FDA staff reviewers recommended against accelerated approval for the candidate, citing concerns with the trial method and outcomes, specifically the possibility for investigator bias.

The decision is a good sign for the troubled cancer vaccine field, which has hit some rough patches in the last year–including flops of GlaxoSmithKline’s ($GSK) MAGE-A3 and Merck KGaA‘s tecemotide. The former jab failed to reach endpoints for non-small cell lung cancer and previously failed to outperform placebo in a melanoma trial, while the latter shot failed a PhIII trial in 2012 and a Phase I/II trial of patients with non-small cell lung cancer last year.

With the committee’s thumbs up, Amgen is one step closer to making its therapy just the second vaccine to treat cancer behind the troubled Provenge, approved in 2010 and heralded as a potential blockbuster. That shot’s high price tag, manufacturing issues and competition eventually led to maker Dendreon‘s bankruptcy. Last year, Valeant ($VRX) picked up the biotech and its Provenge for $400 million in an auction.

Though the vote was for T-Vec as a solo treatment, Amgen is also putting the jab to the test in combination with immunotherapies from Bristol-Myers Squibb ($BMY) and Merck ($MRK).

http://www.fiercevaccines.com/story/amgen-wins-fda-panel-nod-t-vec-melanoma/2015-04-29