– 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.