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.
Amgen's first-in-class oncolytic drug wins FDA approval with combo studies on deck
Amgen won a landmark approval for a re-engineered virus designed to fight skin cancer, preparing to launch a first-of-its-kind therapy that could star in future combination treatments.
Amgen's T-Vec inches toward EU approval for melanoma
Amgen 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.
While the FDA deliberates whether to approve Amgen's melanoma-fighting vaccine, T-Vec, as a monotherapy, the California biotech is partnering with Merck to test T-Vec in combination with the PD-1 drug, Keytruda, in patients with head and neck cancer.
FDA staffers had their doubts this week heading into an advisory committee meeting on Amgen's 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.
FDA panel gives a thumbs up to Amgen's T-Vec for melanoma
Amgen's regulatory team for talimogene laherparepvec (T-Vec) was grilled by a group of outside FDA experts who picked up on some major questions regarding the Phase III melanoma study that was used to back its new drug application. A vigorous defense of the drug, though, helped make a winning case for the therapy, which was ultimately supported by all but one member of the panel.
UPDATED: FDA review challenges Amgen on a questionable T-Vec study
An internal FDA review of Amgen's study of its cancer-killing virus talimogene laherparepvec (T-Vec), released Monday morning, raises red flags for this drug, presenting some thorny questions for the company's regulatory team to answer.
Will FDA advisers shoot down Amgen's cancer vaccine?
Amgen has high hopes for its new cancer vaccine, barreling toward global approvals with positive data in melanoma. But a narrow miss on one key endpoint could present a major hurdle, and Amgen will soon get a chance to defend the treatment before a panel of FDA advisers.
Amgen's cancer vaccine candidate may be awaiting FDA and EMA approval as a melanoma monotherapy, but like many of its peers, it's also looking to explore its prospect's potential as part of an immunotherapy duo, and now it's kicked off a trial combining its treatment with Merck's anti-PD-1 therapy that should help it do just that.
Amgen and Merck kick off a combo cancer trial
Amgen and Merck have launched an early-stage trial pairing their respective cancer immunotherapies, looking to confirm the clinical and commercial promise of combination approaches to cancer.