Use, FDA approves larotrectinib: a drug for many cancers

• THE NEW MEDICINE
Larotrecnib, which can be used in adults and children, is a highly selective inhibitor of NTRK fusion proteins, resulting from a genetic alteration that occurred during the fusion of the TRK gene (tropomyosin receptor) with other Genoa. place for the synthesis of hybrid elements. The fact is that these elements, the TRK fusion proteins, function as a switch, that is, they "illuminate" the tumor, thereby stimulating the multiplication of tumor cells. The mechanism was discovered in the 1980s. Since then, more than 50 different genes that can be fused to a TRK gene have been identified. In the most common tumors, this fusion occurs sporadically (0.5-1% of cases), but in rare forms (eg salivary gland tumors, juvenile bad cancer or pediatric fibrosarcomas) over 90 In 2016, the FDA had granted larotrectinib the status of an innovative therapy for the treatment of solid pediatric tumors and non-operable or metastatic adults, positive for TRK fusion, which worsened despite traditional chemotherapy or could not be treated in another way.

• STUDIES
The efficacy of larotrectinib has been studied in three clinical trials involving 55 diabetic patients and adults with up to 17 different types of solid tumors per affected organ, carriers of TRK fusion, none of Had responded to standard treatment. Larotrectinib demonstrated an overall response rate of 75%. An answer that in 73% of cases lasted at least six months and in 39% per year or more. Among the types of tumors positive for TRK fusion that have responded well to the drug include soft tissue sarcoma, salivary gland cancer, infantile fibrosarcoma, thyroid and lung cancer. Fatigue, nausea, cough, constipation, diarrhea, dizziness, vomiting and increased blood levels of AST and ALT transaminases are common side effects reported by treated patients.

READ – A drug for 17 different types of cancer

"Today's approval – said FDA Commissioner Scott Gottlieb – marks another important step forward in the process of changing to treat tumors based on their genetics rather than on the site of origin […] and reflects advances in the use of biomarkers to guide drug development and targeted drug delivery. This type of drug development program, which involves patients with different tumors but with a common genetic mutation, would not have been possible a decade ago because we knew much less about tumor mutations. "