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The US FDA has approved Eli Lilly’s
drug combination to treat adults with a type of advanced
breast cancer that has spread to other parts of the body, the
drugmaker said on Friday.
Here are some details:
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The combination, Inluriyo-Verzenio, is meant for patients
whose tumors are estrogen receptor-positive, HER2-negative and
carry an ESR1 mutation, and whose cancer has worsened after at
least one hormone treatment. -
About half of the patients with ER-positive, HER2-negative
metastatic breast cancer develop an ESR1 mutation during or
after treatment with a widely used class of hormone-blocking
therapies, Lilly said. -
The US Food and Drug Administration had approved Inluriyo
in September last year to treat metastatic breast cancer, also
called Stage IV breast cancer with ESR1 mutations. -
The approval was based on a late-stage study of 159
patients with this type of advanced breast cancer. Patients who
took both drugs went a median of 11.1 months before their cancer
worsened, compared with 5.5 months for those who took Inluriyo
alone. -
HR+/HER2- is the most common subtype of breast cancer —
the second leading cause of cancer death in women. -
Inluriyo is a daily pill that blocks and breaks down
estrogen receptors that can help some breast cancers grow, while
Verzenio is a twice-daily pill that slows cancer-cell division. -
The combination also carries risks, Lilly said, including
severe diarrhea, low white blood cell counts, lung inflammation,
liver problems and blood clots. -
Inluriyo’s label includes a warning for embryo-fetal
toxicity, which refers to potential risk of harm to a developing
embryo and fetus if exposure occurs during pregnancy. -
Lilly said Inluriyo plus Verzenio is available immediately
in the United States.