Days after Eli Lilly ($LLY) announced that Richard Gaynor, its SVP of clinical development for its oncology arm, would be retiring, the Big Pharma has announced a much-needed boost that its experimental soft tissue cancer drug olaratumab has been recommended for approval in Europe.
Among a series of decisions released today, the EMA’s drug safety and efficacy arm the CHMP gave the green light to olaratumab (which will be called Lartruvo), in use with doxorubicin, for patients with advanced soft tissue sarcoma (STS) who cannot be treated adequately with radiotherapy or surgery, and who have not been treated with doxorubicin.
A final decision on whether the drug should be approved will be made by the European Commission within the next three months. The EMA assessed the med under its accelerated review program, speeding up its overall time to approval.
This puts the drug on the path toward its first-ever marketed approval, as Lilly awaits a decision from the FDA--which in May gave the med its priority review tag, adding to its breakthrough, fast-track and orphan labels. A U.S. decision could also come before the end of the year.
If approved, it will need to compete with Janssen’s ($JNJ) Yondelis (trabectedin), a chemotherapy-type drug for advanced, STS 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 (LY3012207) attaches to PDGFRα on sarcoma cells, it is expected to block its activity, thereby slowing down the growth of the cancer.
The recommendation 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 the CHMP’s decision is contingent on Lilly coming up with the goods from its ongoing Phase III study, which will need to at least match its mid-stage data, the CHMP said.
This study, known as ANNOUNCE, is already fully enrolled. In a statement, Lilly said: “Until availability of the full data, the CHMP will review the benefits and risks of olaratumab annually to determine whether the conditional marketing authorization can be maintained.”
The outgoing Gaynor, SVP of product development and medical affairs for Lilly Oncology, said: “Advanced soft tissue sarcoma is a rare disease that is difficult to treat, and this milestone brings us one step closer to providing physicians in Europe with a new option that they can offer to their patients.”