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Briefing
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- Approved Unique Cancer Drug – U.S. Food and Drug Administration (FDA) accelerated approval for cancer drug Keytruda, made by Merck & Co., that treats cancer based on microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) genetic biomarker, rather than location of tumor
- Genetic Biomarker – Commonly present in colorectal, endometrial and gastrointestinal cancers, and less common in breast, prostate, bladder and thyroid gland cancers, with 30,000 patients in U.S. exhibiting biomarker annually
- How It Works – Drug mobilizes immune system, targeting proteins called programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1), to fight cancer cells
- Study Results – Test shows 40% of 149 patients with 15 different cancers had experienced complete or partial shrinkage of tumors
- Eligible Patients – Approved only for patients whose chemotherapy and other alternative treatments have failed
- Cost – Costs $150,000 per year, with genetic tests to detect presence of biomarker priced between $300 and $600
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Accelerator
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Sector
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Healthcare/Health Sciences
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Organization
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Merck & Co. Inc., U.S. Food and Drug Administration
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Source
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Grover, N. and Berkrot, B., "FDA clears first cancer drug based on genetics of disease, not tumor location",
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Mullin, E., "Drug is first to treat cancer based on genetics, not location",
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"FDA approves first cancer treatment for any solid tumor with a specific genetic feature,"
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AcceleratingBiz analysis
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Original Publication Date
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May 23, 2017
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