CHMP recommends variation to indication of Retsevmo (selpercatinib) to include treatment of adults and adolescents with RET fusion-positive thyroid cancer that is radioactive iodine-refractory
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 to include treatment of adults and adolescents with RET fusion-positive thyroid cancer that is radioactive iodine-refractory.
For information, the full indications for Retsevmo will be as follows: Retsevmo as monotherapy is indicated for the treatment of adults with: • advanced RET fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with: • advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate) . • advanced RET-mutant medullary thyroid cancer (MTC).
150 mins
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