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Pfizer Continues to Work on Ibrance Label Expansion in 2016

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Ibrance label expansion

To strengthen the position of the advanced breast cancer CDK (cyclin-dependent kinases) 4/6 inhibitor drug Ibrance’s position in the oncology market, Pfizer (PFE) has been actively involved in increasing the number of Ibrance-approved indications. Based on real-world and clinical trial data, the company expects Ibrance to pose strong competition to upcoming CDK 4/6 inhibitor therapies from Novartis (NVS) and Eli Lilly (LLY).

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Combination with Letrozole

On February 03, 2015, Ibrance in combination with letrozole was approved by the FDA (US Food and Drug Administration) to treat advanced breast cancer that is hormone receptor (HR+) positive and human epidermal growth factor receptor 2 (HER2-) negative. This approval, however, only includes patients who have not yet undergone an endocrine-based therapy.

The FDA explains Ibrance’s function the following way: “Ibrance works by inhibiting molecules, known as cyclin-dependent kinases 4 and 6, involved in promoting the growth of cancer cells.”

According to the FDA’s press release, “Breast cancer in women is the second most common type of cancer in the United States. It forms in the breast tissue and in advanced cases, spreads to surrounding normal tissue. The National Cancer Institute estimates that 232,670 American women were diagnosed with breast cancer and 40,000 died from the disease in 2014.”

These statistics underline the magnitude of growth opportunity available for Ibrance in the US. To capitalize on this opportunity, Pfizer (PFE) has been actively striving to launch Ibrance across multiple categories of breast cancer.

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Combination therapy with fulvestrant

On February 19, 2016, the FDA approved Ibrance in combination with fulvestrant in women suffering from advanced types of breast cancer. Eligible patients include those who have suffered from disease progression after receiving endocrine therapy. Based on these approved indications, Ibrance has managed to pose strong competition for established breast cancer drugs like Novartis’ Afinitor and Celgene’s (CELG) Abraxane.

Combination with endocrine therapy

In collaboration with Alliance Foundation Trials and the Austrian Breast & Colorectal Cancer Study Group, Pfizer is working on a Phase 3 clinical trial to test if Ibrance can prove beneficial for patients suffering from early-stage breast cancer. This study is known as Palbociclib Collaborative Adjuvant Study, and the trial is based on patients suffering from hormone receptor (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

Notably, Pfizer makes up about 7.3% of the total portfolio holdings of the Health Care Select Sector SPDR Fund (XLV).

In the next part, we’ll discuss the growth prospects of Xalkori in greater detail.

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