News
The Food and Drug Administration has granted accelerated approval to Tabrecta™ (capmatinib; Novartis).
Drugs in the Pipeline
The sBLA was supported by data from the phase 3 TOPAZ-1 trial.
Drugs in the Pipeline
Sintilimab is an investigational programmed death receptor-1 (PD-1) inhibitor.
News
The decision was made to withdraw the application after the Companies and the FDA were not able to align on certain postmarketing studies.
Drugs in the Pipeline
The phase 3 trial evaluated the efficacy and safety of cemiplimab in women 18 years of age and older with recurrent or metastatic cervical cancer, including those with either squamous cell carcinoma or adenocarcinoma.
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.
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.
News
The approval was based on data from the phase 3 IMpower110 study that compared the efficacy and safety of atezolizumab monotherapy to platinum-based chemotherapy in PD-L1-selected, chemotherapy-naive patients with stage IV NSCLC without ALK or EGFR mutations.
News
The FDA has granted accelerated approval to Retevmo™ (selpercatinib; Lilly).