Pfizer Inc (PFE) Earns FDA Approval For Breast Cancer Drug

Pfizer Inc. has garnered FDA approval to begin marketing and selling a breast cancer drug called Ibrance. The company gained the go-ahead through a fast-track approval process designed to push new cancer drugs onto the market.

Ibrance is considered to be one of Pfizer’s most promising developments, and could bring in more than $3 billion in revenues by 2019, according to a Bloomberg survey of analysts. By comparison, Celebrex, one of the company’s top-selling drugs, earned $2.9 billion in 2013 according to Statista. Overall, the company brought in $51.6 billion in revenue worldwide that year, with cancer-related drugs accounting for about $14.9 billion.

The Food and Drug Administration’s decision comes more than two months earlier than the agency’s original schedule had stated, after Ibrance received “breakthrough therapy designation” and a priority review by the FDA based on results of clinical trials that demonstrated a significant jump over current treatments.

Ibrance works by inhibiting molecules that encourage cancer cells to grow and is meant for older women whose cancer has spread throughout the body. In trials, Pfizer showed that patients treated with Ibrance lived for about 10 months longer before their disease worsened than those who did not receive the drug. Long-term survival data is still pending. Breast cancer is the second most common cancer in the U.S. and afflicts 232,670 American women each year, according to the FDA.