The conditional marketing authorisation of Retsevmo® (selpercatinib) was based on positive results from the LIBRETTO-001 Phase I/II trial.
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The EMA's human medicines committee has released its results for the December meeting, suggesting which therapies should receive marketing authorisation.
Priority review has been given to the NDA for selpercatinib to treat advanced RET fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer.
8 July 2016 | By Victoria White, Digital Content Producer
Eisai has expressed concern that patients in England and Wales will have to wait three years to access Lenvatinib due to a ‘black hole’ in the CDF process...
12 May 2016 | By Victoria White, Digital Content Producer
The FDA has granted Orphan Drug Designation for selumetinib for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC)...
2 March 2016 | By Victoria White, Digital Content Producer
The trial will evaluate sulfatinib in locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer or medullary thyroid cancer....