CHMP positive for conditional approval for Retsevmo for RET-fusion positive non-small cell lung cancer (NSCLC), RET-fusion positive thyroid cancer and RET-mutant medullary-thyroid cancer.- Eli Lilly.

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Retsevmo, intended for the treatment of cancers that display rearranged during transfection (RET) gene alterations: RET-fusion positive non-small cell lung cancer (NSCLC), RET-fusion positive thyroid cancer and RET-mutant medullary-thyroid cancer (MTC). The applicant for this medicinal product is Eli Lilly Nederland B.V. Retsevmo will be available as 40 and 80 mg hard capsules. The active substance of Retsevmo is selpercatinib, a RET receptor tyrosine kinase inhibitor (ATC code: L01EX22), inhibiting wild-type RET receptor tyrosine kinase and multiple mutated isoforms. Certain point mutations in RET or chromosomal rearrangements involving in-frame fusions of RET with various partners can result in constitutively activated chimeric RET fusion proteins that can act as oncogenic drivers by promoting cell proliferation of tumour cell lines. The benefits with Retsevmo are its objective response rate and response duration in patients with RET-fusion positive NSCLC or thyroid cancer and RET-mutant MTC who have been previously treated.