- Eli Lilly on Thursday said it is working to pull its cancer medicine Lartruvo from global markets, about three months after the pharma disclosed the drug failed a Phase 3 study
- The Food and Drug Administration conditionally approved Lartruvo in October 2016 as a frontline treatment for certain types of soft tissue sarcoma. However, Lilly's confirmatory trial failed, leading the Indianapolis drugmaker to suspend promotion in January.
- Lilly has set up a program to allow patients already on the drug to carry on with treatment — even after withdrawal — if they've been informed of the study results and risks of continuing therapy. "Establishing this program will give patients who are currently taking Lartruvo the opportunity to continue their treatment program uninterrupted," Anne White, president of Lilly Oncology, said in an April 25 statement.
Lartruvo (olaratumab) was the first new drug approved for soft tissue sarcoma in more than four decades, at the time offering patients with the tough-to-treat tumor type another option beside doxorubicin, a chemotherapy.
The FDA's OK was based on data from an earlier, smaller study that showed signs of benefit. Yet the larger ANNOUNCE trial, results of which were disclosed in January, found pairing Lartruvo with doxorubicin didn't help patients live any longer than those taking just doxorubicin.
Lartruvo's failure, and Lilly's subsequent move to withdraw the drug, are a blow to the company's oncology business. Despite the disappointment — particularly for patients — the setback hasn't weighed down Lilly's stock much.
In fact, since disclosing the Phase 3 results, the company's stock has held roughly even, at a share price that is more than 40% higher versus a year ago.
Executives have also discounted any longer-term financial impact from the clinical miss and anticipated market withdrawal.
"Even with the impact of Lartruvo coming out, we're confident in achieving our sales goal for 2020, which would be the 7% compound annual growth rate for the pharma business between 2015 and 2020," said Joshua Smiley, Lilly's chief financial officer, on the company's fourth quarter earnings call.
However, the trial failure was cited as one of several reasons Lilly lowered its 2019 revenue forecast by $200 million in February.
Lartruvo earned slightly more than $300 million in sales for 2018. The company previously estimated taking an impairment charge in the first quarter related to the cancer drug of about $80 million.
On Thursday, Lilly outlined a new program to allow Lartruvo patients to continue their treatment program following the withdrawal. According to the company, patients would need to be informed of the drug's risks and the Phase 3 trial failure before deciding if they wish to continue on the regimen.
Both U.S. and European regulators advised doctors to not start patients on Lartruvo a few days after the January study disclosure. The European Medicines Agency added that doctors can keep their patients on the drug if they appear to be benefiting, while estimating there are 1,000 European patients currently on the drug.
Lilly's first quarter earnings call is set for April 30 at 9 a.m.