Corporate Member Update-Lilly: New FDA Approval for Retevmo™

Corporate Member Update-Lilly: New FDA Approval for Retevmo™

May, 2020

Lilly USA, LLC is pleased to announce that the US Food and Drug Administration (FDA) has approved Retevmo™ (selpercatinib, 80-mg and 40-mg capsules) on May 08, 2020 for the treatment of:

Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC)
Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy
Adult and pediatric patients 12 years of age and older with advanced or metastatic

RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

These indications are approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.>

Retevmo is now available for ordering, and shipping is anticipated to begin on or after the week of May 11, 2020.

I look forward to scheduling time to review the clinical information associated with this

newly approved treatment option for patients with certain RET-driven cancers.

Please see Important Safety Information below and click for full Prescribing Information for Retevmo.

IMPORTANT SAFETY INFORMATION

 
 
Become a NOS Member Today!
 

Platinum Corporate Members

Gold Corporate Members