Posted by Michael Wonder on 21 Jun 2021
Notice of Compliance with Conditions granted for Retevmo (selpercatinib), the first therapy in Canada specifically for patients with advanced RET driven lung and thyroid cancers
21 June 2021 - Conditional marketing authorisation based on data from LIBRETTO-001 Phase 1/2, the largest trial ever reported in patients with RET driven cancers.
On 15 June 2021, Health Canada issued a Notice of Compliance with Conditions for Retevmo (selpercatinib).
Retevmo is indicated as monotherapy for the treatment of:
- Metastatic RET fusion positive non-small cell lung cancer in adult patients,
- RET mutant medullary thyroid cancer in adult and paediatric patients 12 years of age and older with unresectable advanced or metastatic disease,
- RET fusion positive differentiated thyroid carcinoma in adult patients with advanced or metastatic disease (not amenable to surgery or radioactive iodine therapy) following prior treatment with sorafenib tosylate and/or lenvatinib mesylate.
