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The data supporting drug approval are weaker than you think. The FDA excludes patients with microsatelite instability (MSI)-high from their calculation of TMB RRs for good reason. We already have an approval for pembrolizumab in MSI-high tumors. Now, we want to know the RR in microsatelite stable (MSS)/TMB-high tumors. However, bizarrely, the FDA does not extend this logic to tumor types that already have PD-1 or PD-L1 Ab approvals.
Highlights • The COVID-19 pandemic has reshaped health-care systems worldwide. • Cancer treatment pathways and treatment have been modified. • Roughly 20% of patients develop complications and 3-6% die from COVID-19. • Patients with malignancy are more susceptible to severe infection and mortality from COVID-19. • Metastatic lung cancer and haematological cancer patients appear to be at greatest risk of severe complications and mortality from COVID-19.
In a recent article in Annals of Oncology, Shuler et al. [1] conclude that ‘Afatinib plus paclitaxel improved PFS and objective response rate compared with single agent in patients who acquired resistance to Tyrosine Kinase inhibitors (TKIs).
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