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Eli Lilly said on Friday its cancer treatment Lartruvo, approved on an accelerated basis in 2016, failed to improve patient survival in a long-term study and will no longer be prescribed, driving shares down 3 percent before the bell.
The company said it expects to take a charge in the first quarter of 2019 as a result of the failure and will have an impact on its full-year 2019 forecast.
Lartruvo was granted accelerated approval based on mid-stage trial data by the U.S. Food and Drug Administration and a conditional approval by the European Medicines Agency in 2016, with continued approval remaining contingent on the results of a late-stage trial.
On Friday, Lilly said the study did not confirm the clinical benefit of Lartruvo, used in combination with the standard-of-care chemotherapy doxorubicin, when compared to doxorubicin alone.
The company said it was working with global regulators to determine the appropriate next steps for the treatment.
While these discussions are ongoing, patients with advanced or metastatic soft tissue sarcoma currently receiving Lartruvo may continue their course, if they are receiving clinical benefit, the company said.
Sarcomas are a relatively rare type of cancer that usually develop in the connective tissue of the body, including blood vessels, nerves, bones and muscles.
For patients who have not previously received Lartruvo, the trial results do not support initiating the treatment. The company said it is suspending promotion of the drug at this time.
Lartruvo was expected to bring in $374.50 million in 2019, according to IBES data from Refinitiv.
Last week, Lilly said it would buy Loxo Oncology Inc for $8 billion to expand its presence in the lucrative oncology market.
The company said it expects to take a first-quarter charge, related to Lartruvo, in the range of $70 million to $90 million pre-tax, or about 10 cents per share after tax.
Lilly also said it expects the trial failure to have an impact of about 17 cents per share on its full-year 2019 earnings forecast, but does not see a change in its 2020 minimum financial goals.