Drugs in the Pipeline
Results showed the median OS was 21.4 months in the pembrolizumab plus ipilimumab arm compared with 21.9 months in the pembrolizumab monotherapy arm.
News
The approval was based on data from an open-label phase 1/2 trial in patients aged 1 to 21 years that included 26 patients with relapsed or refractory, systemic ALK-positive ALCL after at least 1 systemic treatment.
Drugs in the Pipeline
Tiragolumab is a monoclonal antibody that works by binding to TIGIT, a protein receptor on immune cells, and blocking its interaction with the poliovirus receptor.
Drugs in the Pipeline
The sNDA is supported by data from the phase 3 CROWN study comparing lorlatinib to Xalkori in 296 adults with advanced ALK-positive NSCLC.
News
The approval was based on data from the double-blind, placebo-controlled phase 3 ADAURA study.
News
The approval was based on data from the phase 1/2 ARROW trial which evaluated the efficacy and safety of Gavreto in patients with RET-mutant MTC.
News
The approval was based on data from several clinical trials, including the phase 3 PACIFIC trial and the phase 3 CASPIAN trial.
Drugs in the Pipeline
Topline results from the trial showed that compared with chemotherapy, treatment with cemiplimab-rwlc reduced the risk of death by 32% in the overall trial population.
Drugs in the Pipeline
The sNDA is supported by data from the phase 3 ADAURA trial that assessed osimertinib vs placebo in 682 patients with early-stage EGFRm NSCLC after complete tumor resection with or without adjuvant chemotherapy.
News
The approval was based on a pre-specified interim analysis from the open-label phase 3 CheckMate -743 trial.
