Cancer drug from Germany's Bayer gets US approval
November 27, 2018
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.
Praise for a 'tissue-agnostic' treatment
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.
In a statement, Bayer said the approval marked "a major paradigm shift in how we treat cancer – treating based on the genomic alteration, rather than a specific tumor site."
"The US FDA approval also bears testimony to Bayer and Loxo Oncology's commitment to advance the future of cancer care while providing true value for patients and physicians."
The first of its kind
Until Monday, there had been no treatment for cancers with the TRK gene mutation, the FDA said. The approval of Vitrakvi means that certain types of highly advanced solid tumors that are metastatic (spreading), unable to be surgically removed and do not qualify for other treatments can now be effectively treated. The approval reflects a development in cancer treatment drugs away from body location-specific medicine to treatments based on genetic defects and mutations. It is the first commercial medicine for Loxo, a Connecticut company that develops treatments for genomically defined cancers.
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Will the treatment be available immediately? Vitrakvi received an "accelerated approval" from the FDA based on the previous clinical trials. However, further clinical trials are needed to confirm the drug's benefit. The FDA said the sponsor is planning to conduct such studies.
Going forward with gene-based medicine: Bayer plans to talk with payers about expanding routine testing for cancer mutations among more cancer patients so that those who could benefit from the new drug can be identified, Reuters reported. Loxo plans to continue developing more cancer drugs based on gene mutation.