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Retsevmo (selpercatinib)

Region

🇪🇺 EU

Active substance

selpercatinib

Company

Eli Lilly Nederland B.V.

Status

Authorised

Therapeutic area

Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms; Cancer

CHMP opinion

Thu 10 Dec 2020

EU approval

Thu 11 Feb 2021

Application

EMEA/H/C/005375

ATC

L01EX22

Official record

www.ema.europa.eu

Indication

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. For biomarker-based patient selection, see section 4.2.  Retsevmo as monotherapy is indicated for the treatment of adults and paediatric patients 2  years of age and older with: advanced RET fusion positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate) . For biomarker-based patient selection, see section 4.2. advanced RET mutant medullary thyroid cancer (MTC) . For biomarker-based patient selection, see section 4.2. 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). For biomarker-based patient selection, see section 4.2.

Regulatory milestones

No milestones recorded in the last year.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.