19 October 2016 - Lartruvo received the FDA's breakthrough therapy designation and was approved under the Agency's accelerated approval program.

Eli Lilly and Company announced today that the U.S. FDA has granted approval of Lartruvo (olaratumab 10 mg/mL injection), in combination with doxorubicin, for the treatment of adults with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.

Lartruvos indication is approved under accelerated approval, and is based on data from the Phase 2 portion of the pivotal JGDG trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Lartruvo, in combination with doxorubicin, is the first FDA-approved front-line therapy for soft tissue sarcoma in four decades. 

The confirmatory Phase 3 trial, ANNOUNCE, is fully enrolled.

Read Eli LIlly press release

Read FDA press release