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.
News
The FDA has approved Gavreto™ (pralsetinib; Blueprint Medicines and Genentech) for the treatment of adults with metastatic RET fusion-positive NSCLC.
