Retifanlimab Under Review for Anal Squamous Cell Carcinoma
The BLA is supported by data from the POD1UM-202 trial that evaluated retifanlimab in 94 adults with locally advanced or metastatic SCAC who progressed after platinum-based chemotherapy.
The BLA is supported by data from the POD1UM-202 trial that evaluated retifanlimab in 94 adults with locally advanced or metastatic SCAC who progressed after platinum-based chemotherapy.
The sBLA submissions were based on data from the CheckMate -649 and CheckMate -577 trials.
Although the definition of remission varies, the goal of IBD treatment is to achieve and sustain remission.
The approval was based on data from the phase 2 DESTINY-Gastric01 trial.
The approval was based on data from the open-label, active-controlled phase 3 ANDROMEDA study.
The designation is based on positive topline data from a phase 2 study of 120 adults following open-heart surgery.
While DAAs have improved the treatment of chronic HCV infection by eliciting higher rates of sustained virologic response, they also interact with a number of agents that could potentially limit their effectiveness.
Risankizumab is currently FDA-approved under the brand name Skyrizi for the treatment of moderate to severe plaque psoriasis.
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The Company has begun shipping both the 8mcg and 24mcg capsules; the capsules are supplied in 60-count bottles.