What is the generic name?

SELPERCATINIB

What is the Trade Name for SELPERCATINIB?

RETEVMO

What are the Indications for SELPERCATINIB?

• 1 INDICATIONS AND USAGE RETEVMO‚Ñ¢ is a kinase inhibitor indicated for the treatment of: Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) 1 ( 1.1 ) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET -mutant medullary thyroid cancer (MTC) who require systemic therapy 1 ( 1.2 ) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) 1 ( 1.3 ) 1 This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). 1.1 Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer RETEVMO‚Ñ¢ is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC). This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.1 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). 1.2 RET -Mutant Medullary Thyroid Cancer RETEVMO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET -mutant medullary thyroid cancer (MTC) who require systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.2 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). 1.3 RET Fusion-Positive Thyroid Cancer RETEVMO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.3 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

References: https://open.fda.gov/