Overall Survival Data Added to Nubeqa Prescribing Information
Nubeqa, an androgen receptor inhibitor, was approved for the treatment of patients with nmCRPC based on data from the placebo-controlled phase 3 ARAMIS trial.
Nubeqa, an androgen receptor inhibitor, was approved for the treatment of patients with nmCRPC based on data from the placebo-controlled phase 3 ARAMIS trial.
Orgovyx is an oral nonpeptide gonadotropin-releasing hormone (GnRH) receptor antagonist.
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.
In 2018, the FDA granted accelerated approval to Opdivo for SCLC based on data from the phase 1/2 CheckMate -032 trial.
The sNDA is supported by data from the phase 3 CROWN study comparing lorlatinib to Xalkori in 296 adults with advanced ALK-positive NSCLC.
The sNDA approval is based on efficacy and safety data from the open-label phase 2 OPTIC trial and 5-year data from the phase 2 PACE trial.
The approval was based on data from the double-blind, placebo-controlled phase 3 ADAURA study.
The approval was based on data from the BOSTON trial that assessed Xpovio in combination with bortezomib and dexamethasone in 402 adults with relapsed or refractory multiple myeloma who had received 1 to 3 prior therapies.
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.
The approval was based on efficacy and safety data from 2 prospective clinical trials.