Loncastuximab tesirine is an antibody drug conjugate composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine dimer cytotoxin.
The approval was based on data from several clinical trials, including the phase 3 PACIFIC trial and the phase 3 CASPIAN trial.
Interim analysis shows risk for disease progression or death lower for first-line therapy with lorlatinib versus crizotinib
The latest on the vaccine development from Moderna, and BioNTech and Pfizer as they release more trial data; An at-home diagnostic test is approved; Keytruda gains expanded approval; And all the rest of the drug news from this past week.
The approval was based on data from the phase 3 KEYNOTE-355 trial that pembrolizumab plus chemotherapy in adults with locally recurrent inoperable or metastatic TNBC, who had not been previously treated with chemotherapy in the metastatic setting.
CellProtect (XNK Therapeutics) is an autologous ex vivo expanded and activated NK cell-based therapy, which is produced by selective expansion and activation of NK cells from the peripheral blood of patients with cancer.
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.
This week we cover a study that identified factors associated with strong antibody responses to COVID; How convalescent plasmas benefits may be limited; A nasal spray to treat diabetic gastroparesis; Recommendations for colorectal cancer screening; And a new treatment approved for dry eye disease. And of course, movie trivia!
The supplemental Biologics License Application includes data from the open-label, randomized phase 2 DESTINY-Gatric01 trial.
Benefit substantial for adults aged 50 to 75 years; benefit moderate for adults aged 45 to 49 years.
