FDA on Lilly's Lartruvo: No New Patients Outside an Investigational Study
Just a day after a similar European Medicines Agency (EMA) warning, the US Food and Drug Administration (FDA) late Thursday recommended that Eli Lilly’s Lartruvo (olaratumab) should not be initiated in new patients outside of an investigational study.Both agencies noted how a recently completed Phase 3 study did not confirm the clinical benefit of Lartruvo. “Specifically, the study did not meet the primary endpoint of improvement in overall survival for Lartruvo and doxorubicin as compared to placebo and doxorubicin,” FDA said.
FDA also recommended that patients who are currently receiving Lartruvo should consult with their healthcare providers about whether to remain on the treatment. The agency said it is currently reviewing the most recent data and working with Lilly to determine appropriate next steps.
Like its European colleagues, FDA approved Lartruvo in combination with doxorubicin for certain adult patients with soft tissue sarcoma not amenable to curative treatment. But the approvals in both regions were provisional, contingent on the postmarket study’s success.
The approvals came as the Lartruvo combination with doxorubicin previously showed an overall survival benefit in soft tissue sarcoma in a 133-patient, US-only, randomized Phase 2 trial.