Eli Lilly began its US commercial rollout of Inluriyo (imlunestrant) on Tuesday, days after the Food and Drug Administration cleared the drug in combination with Verzenio for advanced breast cancer. The Indianapolis-based company confirmed availability for oncology clinics.
The FDA approval cleared the Inluriyo-Verzenio combination for adults with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer whose disease progressed after prior endocrine therapy. Trial data showed improved median progression-free survival versus standard endocrine treatment in patients carrying ESR1 mutations.
Inluriyo joins a competitive class of next-generation oral endocrine therapies that includes AstraZeneca's Orserdu (elacestrant), approved in 2023 for ESR1-mutated tumours. Lilly said the new combination broadens options for patients seeking to delay chemotherapy and detailed pricing and patient-assistance programmes alongside the launch.
Oncologists and patient advocacy groups have pressed for more oral treatments that spare patients intravenous chemotherapy in the metastatic setting. Lilly said it would support diagnostic testing to identify ESR1 mutations, which guide eligibility for the therapy.
Breast cancer specialists at major US cancer centres are expected to incorporate the combination into treatment sequencing discussions. Uptake will depend on insurance coverage and companion diagnostic access in community oncology settings.