Summary of opinion: Retsevmo Positive
On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Retsevmo.
- On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Retsevmo.
- The marketing authorisation holder for this medicinal product is Eli Lilly Nederland B.V.
- The CHMP adopted a new indication as follows:
Retsevmo as monotherapy is indicated for the treatment of adults with:
- advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1). - 1New text in bold.