The nation's largest drug-maker is throwing a victory party right now.
One of the most anticipated drugs in Pfizer's (NYSE:PFE) pipeline just got a crucial FDA approval. The drug, (palbociclib, but trade-named Ibrance), treats one of the deadliest forms of breast cancer. And not only did Ibrance get the FDA nod two months ahead of schedule, some analysts analysts expect the oral drug to grow into a blockbuster with as much as $4 billion in sales by 2020.
Ibrance will soon be marketed to an estimated 22,000 women who have advanced ER-positive, HER2-negative breast cancer. Women falling into the ER+, HER2- category represent the largest proportion of breast cancer cases and are usually treated with chemotherapy.
Ibrance is the first-in-class CDK4/6-targeting oral drug. This class of treatments works by inhibiting two enzymes that promote the growth of cancer cells. UCLA, which helped test the drug for Pfizer, said that Ibrance produced "groundbreaking results" and has potential to become a mainstay treatment.
In addition, the FDA's fast approval puts Ibrance well ahead of potential competitor drugs from Novartis and Eli Lilly.
Pfizer's powers into oncology -- and not a moment too soon
Ibrance has been one of the most closely watched oncology drugs in the biopharmaceutical world. Its FDA approval, while early, also came just in time.
Pfizer is facing increasing competition from generic versions of former blockbusters Celebrex, Lipitor, and Viagra, as well as what analysts, such as John Boris from SunTrust Robinson Humphrey, believe is a very thin pipeline. The largest U.S. drug maker badly needs big-selling new drugs to renew its growth.
Recently, Pfizer's sales forecast for 2015 fell short of analyst expectations by some $3 billion. Pfizer said it expected sales of $44.5-$46.5 billion, while analysts had predicted $47.6 billion. To reassure investors in last quarter's earnings release, CEO Ian Read leaned hard on pipeline prospects, particularly Ibrance. "As we look forward to 2015, we expect continued momentum with our pipeline...notably the potential U.S. approval of Ibrance (palbociclib) for advanced breast cancer," he said.
Ibrance's approval also takes some of the pressure off validating Pfizer's big R&D spend on cancer and vaccines. Pfizer was rebuffed by AstraZeneca last year, a pursuit that was appeared motivated in part by the allure of that company's cancer pipeline.
One victory at a time
While investors wait to see how the new cancer immunotherapy pans out, Ibrance, at least, is clearly a big potential winner. The drug was approved for use in postmenopausal women with metastatic cancer. It is to be used in combination with Novartis' Femara, the FDA said.
Ibrance's approval was based on a phase 2 PALOMA clinical trial, which compared Ibrance plus Femara, to Femara alone, in a study of 165 women with advanced breast cancer. Results showed that the combo doubled progression free survival, stopping tumors from growing for more than 20 months.
Pfizer noted that continued approval for the indication might be contingent upon verification and description of clinical benefit in a confirmatory trial.
"Today's FDA approval of Ibrance marks a pivotal milestone that demonstrates the strength of our science, provides an important medicine to patients in need, and underscores the contributions our company can make to society," said Read.
The search for a cure for cancer is a long story, and there is still a lot to be written. But for now, and not just for Pfizer, but for many women experiencing a very devastating diagnosis, there is more hope for a happy ending.
Cheryl Swanson has no position in any stocks mentioned, but she hates to be wrong, so, if it wasn't already too late, she would be buying Pfizer. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.