- The Food and Drug Administration and the European Medicines Agency have recommended doctors should not start patients with soft tissue cancer on Eli Lilly's Lartruvo after a Phase 3 study of the drug failed to show a survival benefit.
- Neither regulator, both of which gave the medicine conditional approvals, indicated whether the drug's marketing status was now in question. About 1,000 patients in the EU are currently being treated with Lartruvo, according to the EMA.
- Doctors can keep their patients on Lartruvo if they appear to be benefiting from the medicine, the EMA said in a statement this week. For its part, the FDA recommended patients receiving Lartruvo consult with their doctor.
The guidance from the FDA and EMA isn't terribly surprising after last week's news of Lartruvo's failure in a Phase 3 study of patients with advanced or metastatic soft tissue sarcoma. Lilly itself has said the results don't support starting treatment with Lartruvo (olaratumab) outside of clinical trials.
Both the EMA and FDA had granted Lartruvo early approval based on Phase 2 results that indicated the medicine could prolong overall survival and progression-free survival when given in combination with the existing cancer treatment doxorubicin. Yet data from the larger Phase 3 trial showed no significant survival benefit when compared with doxorubicin alone.
According to results released by the EMA, combining Lartruvo with doxorubicin didn't reduce the risk of death versus doxorubicin, and actually resulted in a shorter median time to disease progression than the control arm.
Regulators could act to withdraw the drug's approvals, which were contingent on confirmation from larger clinical study, but as of yet have shown no signs of doing so.
The FDA did indicate, however, that it is currently reviewing the data and "working with the company to determine appropriate next steps."
For now, the EMA chose to issue guidance to doctors and patients as it waits for full results from the Phase 3 study. The FDA, which is affected by an ongoing government shutdown in the U.S., did not issue a full press statement, instead updating the original approval statement for Lartruvo.
Importantly, the EMA said the Lilly trial showed no new safety concerns. Side effects for patients being given the combination of Lartruvo and doxorubicin were similar to patients who only got doxorubicin.
In last week's announcement, Lilly said it was suspending promotion of Lartruvo and working with global regulators to determine the medicine's future.