Telaprevir (TVR) has been approved for response-guided-therapy (RGT) of chronic hepatitis C (HCV) genotype-1-infection in treatment-naïve and –experienced patients.
Although the multikinase inhibitor sorafenib has recently been approved for treatment of HCC, poor response of the late-stage cancer to this and almost all other available chemotherapeutic agents continues to be a major obstacle to successful HCC therapy.
Belimumab was the first biologic approved for SLE based on positive responses measured with the SLE Responder Index, which required a decrease in inflammation, no new organ domains being involved, and improvement in physician global assessment.
Also, at that time, their application in patients with an inadequate response to csDMARDs was not yet approved for tocilizumab in the USA and for abatacept in Europe.
All the immunological agents approved for treatment of human cancers activate the T cell responses to cancers [ 1– 3].
This drug has already been approved for renal and hepatocarcinoma treatment and has shown good responses in angiosarcomas [ 24].
with subunit peptide antigens is one of the methods used to enhance the immune response; however, only a few adjuvants are approved for clinical use [16].
Currently, only one drug, sorafenib, is FDA approved for the treatment of advanced hepatocellular carcinoma (HCC), achieving modest objective response rates while still conferring an overall survival benefit.
When Truvada, an HIV-prevention medication, was first approved for preventative use by the FDA in 2012, it received a mixed response.
Xolair, which has been approved for use in patients with asthma (which Tessa also has), blocks the allergic response by inhibiting the IgE antibody that creates anaphylaxis.
Starlink corn was a Bt corn that was initially approved for animal but not human consumption based on the potential for allergenic responses.
