That was fast. Within a week of a surprise trial failure for Eli Lilly’s soft tissue sarcoma drug Lartruvo, regulators on both sides of the Atlantic have warned doctors not to start new patients on the drug.
Following some 24 hours after a similar decision by European regulators, the FDA on Thursday said it “recommends that Lartruvo should not be initiated in new patients outside of an investigational study.” And for patients already on the drug, the FDA says they “should consult with their healthcare provider about whether to remain on the treatment.”
The regulatory moves put Lartruvo’s future further in doubt. Lilly itself had already taken the unusual step of halting its Lartruvo marketing.
All the action follows last week’s bombshell late-stage trial failure in patients with advanced or metastatic soft tissue sarcoma. In that study—which Lilly needed to come up positive to confirm a phase 2 approval—patients on a combo of Lartruvo and doxorubicin didn’t outlive those using doxorubicin alone.
The Lartruvo patients lived a median 20.4 months, compared with 19.7 months in the doxorubicin group, the European Medicines Agency said Wednesday.
Lartruvo won accelerated approval in the U.S. and conditional approval in Europe based on phase 2 data showing it could help patients live significantly longer—26.5 months versus 14.7 months—and hold off cancer progression better than doxorubicin alone. In Europe, the approval was contingent on a finding of benefit in a phase 3 trial.
After reporting the phase 3 failure last week, Eli Lilly stopped promoting the drug and said it was “working with global regulators to determine the appropriate next steps.” The drugmaker said it would take a pre-tax charge of $70 million to $90 million this quarter, and that it expects the miss to take a 17-cent chunk out of earnings per share this year.
Lilly’s Lartruvo stumbles mark a setback for Lilly’s oncology outfit, which the company recently bolstered with an $8 billion buyout of Loxo Oncology. With the deal, Lilly gets an approved “tumor agnostic” TRK inhibitor Vitrakvi, plus several pipeline drugs.