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RETEVMO (nda213246)- (40MG,80MG)

SELPERCATINIB LOXO ONCOL ELI LILLY
40MG,80MG
Yes No
2038-Oct-10 2025-May-08
None None
None No
RETEVMO ® is a kinase inhibitor indicated for the treatment of: • Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test • Adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy • Adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) • Adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
0 0 0
Total Other Developers 2
Drugs with Suitability No
40MG ** ** - - -
80MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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