Loxo, Bayer get FDA nod for Vitrakvi
The Food and Drug Administration has granted accelerated approval to Loxo Oncology's Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature, or biomarker.
This is the second time the FDA has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated. The approval marks a new paradigm in the development of cancer drugs that are "tissue agnostic." It follows the policies that the FDA developed in a guidance document released earlier this year.
Developed in collaboration with Bayer, Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase, or NTRK, gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
"Today's approval of Vitrakvi is the culmination of years of hard work and research by many people to bring the first-ever treatment to patients with TRK fusion cancer. TRK fusions are rare, but occur across many different tumor types. In this era of precision medicine, we are delivering on Bayer's commitment to advance the future of cancer care while providing value for patients and physicians," said Robert LaCaze, a member of the executive committee of Bayer's pharmaceuticals division and head of the oncology strategic business unit. "It is very rewarding to provide a therapy specifically for patients with advanced solid tumors harboring an NTRK gene fusion."
"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. "This new site agnostic oncology therapy isn't specific to a cancer arising in a particular body organ, such as breast or colon cancer. Its approval reflects advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine. We now have the ability to make sure that the right patients get the right treatment at the right time.”
This is the second time the FDA has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated. The approval marks a new paradigm in the development of cancer drugs that are "tissue agnostic." It follows the policies that the FDA developed in a guidance document released earlier this year.
Developed in collaboration with Bayer, Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase, or NTRK, gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
"Today's approval of Vitrakvi is the culmination of years of hard work and research by many people to bring the first-ever treatment to patients with TRK fusion cancer. TRK fusions are rare, but occur across many different tumor types. In this era of precision medicine, we are delivering on Bayer's commitment to advance the future of cancer care while providing value for patients and physicians," said Robert LaCaze, a member of the executive committee of Bayer's pharmaceuticals division and head of the oncology strategic business unit. "It is very rewarding to provide a therapy specifically for patients with advanced solid tumors harboring an NTRK gene fusion."
"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. "This new site agnostic oncology therapy isn't specific to a cancer arising in a particular body organ, such as breast or colon cancer. Its approval reflects advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine. We now have the ability to make sure that the right patients get the right treatment at the right time.”