The US FDA approved Eli Lilly's FDA approval for Verzenio by Eli Lilly on Friday, Sept. 18, clearing Inluriyo and Verzenio for adults with ER-positive, HER2-negative, ESR1-mutated advanced breast cancer after at least one hormone treatment. Lilly said the combination is available immediately in the United States.
The decision gives patients in this subgroup another option after disease progression on hormone therapy. In the late-stage study behind the approval, 159 patients were studied, and the combination delayed cancer worsening for a median 11.1 months, compared with 5.5 months for Inluriyo alone.
Inluriyo and Verzenio
Inluriyo is a daily pill that blocks and breaks down estrogen receptors. Verzenio is a twice-daily pill that slows cancer-cell division. Used together, they target tumors that still rely on estrogen signaling but have picked up an ESR1 mutation, a change seen in about half of patients with ER-positive, HER2-negative metastatic breast cancer during or after treatment with hormone-blocking therapies.
FDA label details
The combination also carries risks that patients and doctors will need to weigh against the longer time before progression. Those risks include severe diarrhea, low white blood cell counts, lung inflammation, liver problems and blood clots.
The US Food and Drug Administration had already approved Inluriyo in September last year for metastatic breast cancer with ESR1 mutations. Friday's action extends that drug into a combination that Lilly said can be used immediately in the United States, giving adults who meet the label a new treatment path without waiting for a later rollout.
United States access
For patients already moving beyond one hormone treatment, the practical change is simple: the combination is now on the market in the United States. The open question is how fully the late-stage study will be read once the full results and safety details from the 159-patient trial are laid out.
