FierceBiotech: Pfizer wins early FDA approval for a potential cancer blockbuster
Pfizer wins early FDA approval for a potential cancer blockbuster
By Damian Garde, FierceBiotech
Feb. 3, 2015
Pfizer ($PFE) picked up a speedy FDA nod for palbociclib, a breast cancer treatment with blockbuster potential, barreling toward the market as it works to carve out a bigger share of the oncology space.
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 $5 billion a year at its peak, according to Leerink analyst Seamus Fernandez.
The approval puts Pfizer ahead of a coming crowd of CDK inhibitors, including promising contenders from Eli Lilly ($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.
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