The drug, which works by inhibiting the enzymes CDK4 and CDK6, is now
cleared for use in postmenopausal women with metastatic breast cancer.
The approval is based on Phase II data and comes more than two months
ahead of the agency's decision deadline, completing what has been a
charmed trip through the regulatory process for Pfizer. The oral
treatment, which will sell as Ibrance, is expected to bring in sales
between $3 billion and $5 billion a year at its peak, according to
Leerink analyst Seamus Fernandez.
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FDA oncology chief Richard Pazdur |
The approval puts Pfizer ahead of a coming crowd of CDK inhibitors, including promising contenders from Eli Lilly (
$LLY) and Novartis (
$NVS),
and gives the company a first major success as it begins a new era in
cancer treatments. Palbociclib's lightning-fast approval also affirms
FDA oncology chief Richard Pazdur's willingness to hurry along so-called
breakthrough treatments that could change the standard of care, a cause
for optimism among developers of similar drugs.
Pfizer's drug is specifically indicated for women whose cancers respond
to estrogen receptor but don't express human epidermal growth factor
receptor 2 (HER2), and it's to be used in combination with the oncology
drug Femara (letrozole), the FDA said.
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