Eli Lilly drug combination approved by FDA for advanced breast cancer

The U.S. Food and Drug Administration has granted full approval to Eli Lilly’s drug combination, Inluriyo and Verzenio, for treating adults with specific types of advanced breast cancer. The treatment is indicated for patients with estrogen receptor-positive (ER-positive), HER2-negative breast cancer that carries an ESR1 mutation and has progressed after at least one hormone treatment.

Clinical data from a late-stage study of 159 patients showed that the combination therapy extended the median time before cancer progression to 11.1 months, compared to 5.5 months for patients receiving Inluriyo alone. Inluriyo is an oral estrogen receptor antagonist, while Verzenio is a CDK4/6 inhibitor.

Inluriyo is also being evaluated in the Phase 3 EMBER-4 trial, a large-scale study involving over 8,000 patients across more than 30 countries, to determine its effectiveness in the adjuvant setting for early-stage breast cancer. The combination therapy is currently available in the United States.