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[DOCX File]AusPAR Attachment 1: Product Information for Nivolumab ...
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Further, the mechanism of action of the two drugs suggest that durvalumab monotherapy is likely to be most effective in patients with a higher PDL1 expression rate, while the addition of tremelimumab may have an additive or synergistic effect to durvalumab monotherapy, thereby improving response rates in those with a lower PDL1 expression rate.
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[DOCX File]Introduction - PBS
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Nov 12, 2019 · Background: Atezolizumab is an antibody (a protein similar to the ones produced by your body's immune system) that blocks the programmed death-ligand 1 (PD-L1) pathway. The PDL1 pathway is involved in regulating the body's natural immune response, but tumors can take advantage of this regulation to partially resist or evade the immune system.
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[DOCX File]AusPAR Attachment 1: Product Information for Avelumab
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However, it is known that the response to immunotherapies (immuno-oncology drugs) may have a later onset but once triggered, is likely to be durable, bringing unquantifiable long-term survival benefit for a subset of patients. This benefit is not captured by the outcome measures ... Subgroups based on PDL1 status and histology have been added ...
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Subgroups based on PDL1 status and histology have been ...
The observed OS (Figure 1, Table 1) benefit was consistently demonstrated across subgroups of patients including baseline ECOG performance status, M stage, history of brain metastases, and baseline LDH level. Survival benefit was observed regardless of whether PDL1 expression was above or below a PDL1 tumour membrane expression cutoff of 5% or 10%.
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Immune Checkpoint Inhibitors and Their Side Effects
In addition, different drugs in this class may have different affinities for the PD-1/PD-L1 epitope and require different PD-L1 expression thresholds for optimal clinical benefit, this information needs to be provided to the pathologist for accurate reporting and to the clinician so that the patient is treated with an appropriate PD-1/PD-L1 ...
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Overview - NantHealth
Third-party payors may limit coverage to specific drug products on an approved list, or formulary, which might not include all of the FDA-approved drugs for a particular indication. Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition ...
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[DOCX File]Clinical trials - Pharmaceutical Benefits Scheme (PBS) | Home
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There are many examples of very rapid listing where drugs have high unmet clinical need, in these circumstances the listing has often occurred significantly in advance of reimbursement in other countries. For example, the TGA registration of pembrolizumab for melanoma was approved on 16 April 2015 and PBS subsidy .
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[DOCX File]MSAC Application Form - Department of Health
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The PSCR also stated that “the estimated post-progression treatment estimate suggests that switching to anti-PDL1 treatment increases survival time by a large factor of 4.09…, [which is] not very precise due in particular to the limited number of patients who were eligible to switch and switched (PSCR, “Adjusting for treatment switchover ...
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[DOCX File]Committee:
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List targets based on DNA/RNA analysis that may be treated by FDA-approved drugs either in an on-label or off-label manner based on peer-reviewed clinical data; List findings that suggest a particular targeted therapy which the physician would otherwise use may not work due to a potential resistance marker;
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[DOCX File]1440-FinalPSD-accessible
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Avelumab binds PDL1 and blocks the interaction between PDL1 and the programmed death 1 (PD1) and B7.1 receptors. This removes the suppressive effects of PDL1 on cytotoxic CD8+ Tcells, resulting in the restoration of antitumour Tcell responses. In syngeneic mouse tumour models, blocking PDL1 activity resulted in decreased tumour growth.
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List of pdl1 drugs