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NOW APPROVED: the First-and-Only FDA-approved PROTAC

A PROTAC is a type of heterobifunctional protein degrader, a novel treatment class

VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)−positive, human epidermal factor receptor 2 (HER2)−negative, estrogen receptor 1 (ESR1)−mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
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2L=second line; ER+/HER2–=estrogen receptor–positive/human epidermal growth factor receptor 2–negative; ESR1m=estrogen receptor 1 mutation; FDA=US Food and Drug Administration; mBC=metastatic breast cancer; PROTAC=PROteolysis-TArgeting Chimera.

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IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
QTc Interval Prolongation
VEPPANU can cause QT (QTc) interval prolongation. Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and during treatment with VEPPANU. Perform an ECG prior to initiation of treatment with VEPPANU and do not initiate VEPPANU in patients with QTc >470 msec. Repeat ECG approximately 4 weeks after initiating treatment and as clinically indicated. Avoid concomitant use of VEPPANU with strong CYP3A inhibitors or drugs known to prolong the QTc interval.

Indication

VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative, estrogen receptor–1 (ESR1)–mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

Important Safety Information

WARNINGS AND PRECAUTIONS

QTc Interval Prolongation

VEPPANU can cause QT (QTc) interval prolongation. Correct electrolyte abnormalities, including hypokalemia
and hypomagnesemia, prior to and during treatment with VEPPANU. Perform an ECG prior to initiation of
treatment with VEPPANU and do not initiate VEPPANU in patients with QTc >470 msec. Repeat ECG
approximately 4 weeks after initiating treatment and as clinically indicated. Avoid concomitant use of VEPPANU
with strong CYP3A inhibitors or drugs known to prolong the QTc interval.