Fast-track designation, breakthrough therapy designation, priority review, orphan drug designation, and now, finally, Eli Lilly ($LLY) gets the full house with an approval for its soft tissue sarcoma (STS) med in the U.S.
Specifically, Lartruvo (olaratumab) has been approved by the FDA under its accelerated program, in combination with doxorubicin, as a front-line therapy for patients with STS.
The new med can be used in patients with STS who cannot be cured with radiation or surgery and who have a type of STS for which an anthracycline is an appropriate treatment.
Richard Pazdur, acting director of the FDA’s Oncology Center of Excellence, said that this was the first new therapy approved by the FDA for the initial treatment of soft tissue sarcoma since doxorubicin’s approval more than 40 years ago.
Janssen’s ($JNJ) Yondelis (trabectedin), a chemotherapy-type drug for advanced STS, also recently gained FDA approval for liposarcoma and leiomyosarcoma.
Lilly’s drug works as a PDGFRα antagonist, with this protein often found on the surface of cells where it is thought to play a role in regulating cell multiplication.
In cancers such as soft tissue sarcoma--which has a high mortality rate although is relatively rare--these proteins are present in high levels or overactive, causing cells to become cancerous. When olaratumab attaches to PDGFRα on sarcoma cells, it is expected to block its activity, thereby slowing down the growth of the cancer.
The FDA approval is based on the results of a Phase II study that showed a significant improvement in the time patients survived with a combination of doxorubicin plus Lartruvo compared to doxorubicin alone (a median gain of 11.8 months).
But Lilly, as with its CHMP recommendation in Europe last month, will also need to publish a confirmatory Phase III study, or face having its med yanked off the market. This study, known as ANNOUNCE, is already fully enrolled.
Lilly was down slightly by 0.27% at the end of play yesterday.