The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2019 > 1 > EMA: No New Patients Should Start Treatment With Lilly’s Lartruvo

EMA: No New Patients Should Start Treatment With Lilly’s Lartruvo

Posted 23 January 2019 | By Zachary Brennan 

EMA: No New Patients Should Start Treatment With Lilly’s Lartruvo

The European Medicines Agency (EMA) on Wednesday told doctors that no new patients should begin treatment with Eli Lilly’s Lartruvo (olaratumab) because a recent study found it is not more effective in combination with doxorubicin for patients with soft tissue cancer when compared to doxorubicin alone.

The EMA warning comes just five days after Lilly announced that the Phase 3 study had failed.

“Specifically, the study did not meet the primary endpoints of overall survival (OS) in the full study population or in the leiomyosarcoma (LMS) sub-population; there was no difference in survival between the study arms for either population,” Lilly said. The company also said it is suspending promotional efforts of Lartruvo.

The Lartruvo combination with doxorubicin previously showed an OS benefit in soft tissue sarcoma in a 133-patient, US-only, randomized Phase 2 trial, which led to accelerated approval by the US Food and Drug Administration (FDA) in October 2016 and conditional marketing authorization by EMA in November 2016. Both of the approvals were contingent on the recent trial results, although FDA has yet to weigh in.

EMA added that for patients currently being treated with Lartruvo, their doctors may consider continuing treatment with the medicine if they appear to benefit. EMA estimates that around 1,000 patients are currently treated with Lartruvo in the EU.

According to Lilly’s most recent quarterly filing, FY 2018 Lartruvo worldwide sales topped $221 million, while 2017 sales were $144 million.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.