The sBLA was based on efficacy and safety data from the KEYNOTE-A18 trial.
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The Agency could not approve the BLA due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.
Lonsurf is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor.
Researchers say they have identified an unintended effect of Medicare’s 340B Drug Pricing Program; increases in spending for outpatient cancer treatments among patients with commercial insurance.
Researchers investigated the association between nonalcoholic fatty liver disease and early-onset colorectal cancer according to anatomical site.
Increased recurrence-free survival seen for patients with high-risk HCC following resection or ablation.
High drug prices and ongoing shortages may prompt cancer patients to buy treatments online and fall prey to illegitimate pharmacies.
The IMbrave050 study included 662 patients with HCC at high risk for recurrence after surgical resection or ablation with curative intent.
At the end of one year, likelihood of being weaned off treatment was higher for eyes treated with aflibercept versus bevacizumab