Cancer drug from German pharma giant Bayer gets US approval

[nitpicker]

https://www.dw.com/en/cancer-drug-from-german-pharma-giant-bayer-gets-us-approval/a-46462315

Cancer drug from German pharma giant Bayer gets US approval

Date 26.11.2018
Author Cristina Burack


The US Food and Drug Administration (FDA) on Monday approved an advanced cancer treatment drug that combats solid tumors caused by a rare genetic mutation.

The drug will be sold under the brand name Vitrakvi in a partnership between US-based pharmaceutical company Loxo Oncology and Germany's Bayer.

How the drug works
Vitrakvi, commonly known as larotrectinib, works by targeting a biomarker, or a gene that identifies a disease. This enables the drug to work across different types of tumors rather than the location in the body where a tumor started.
The mutation that Vitrakvi targets is called neurotrophic tyrosine kinase, or TRK, and is a gene fusion found in solid tumors.
Around 3,000 Americans, or 1 percent of solid tumor cancer patients, are affected by TRK fusion every year, Bayer reported.
In clinical trials Vitrakvi was shown to significantly reduce tumors in 81 percent of patients with 24 different types of cancers while causing only mild side effects.

The FDA said in its press release that "the approval marks a new paradigm in the development of cancer drugs that are 'tissue agnostic,'" using a term applied to drugs that are not linked to tumor location. "Today’s approval marks another step in an important shift toward treating cancers based on their tumor genetics rather than their site of origin in the body," FDA Commissioner Scott Gottlieb said in the statement.
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