Dive Brief:
- Pfizer’s CDK 4/6 inhibitor Ibrance was recommended for a marketing authorization by the European Medicines Agency (EMA) for patients with breast cancer.
- The designation opens the door for EMA review in the ongoing approval process for price and reimbursement, and the potential market for Ibrance in Europe once a final decision is made.
- The hot-selling drug, already approved by the Food and Drug Administration in the U.S., is used for the treatment of women with locally advanced or metastatic breast cancer, in the crowded yet rapidly growing $4 billion market.
Dive Insight:
Breast cancer is the most common cancer in women worldwide, with nearly 1.7 million new cases diagnosed in 2012, including 464,000 new cases in Europe that year.
Ibrance is Pfizer's new shining star in its constellation of drug products. While the drug has strong growth so far, there is also potential competition ahead, particularly from Novartis and Eli Lilly & Co. Prizer has had a first-to-market advantage, but both competitors argue that their respective compounds are best-in-class.
The EMA’s action on Ibrance followed a recommendation from its advisory panel, the Committee for Medicinal Products for Human Use (CHMP), which gave a positive review for the drug to be used in combination with two existing therapies in women who had received prior endocrine therapy.
Ibrance (palbociclib) works by blocking the activity of proteins known as cyclin-dependent kinases (CDK) 4 and 6. Pfizer received FDA approval in 2015 for its use in combination with letrozole as a treatment for postmenopausal women with ER+/HER2-advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
Pfizer said the submission to EMA was based on the final results of two trials (PALOMA-1 and PALOMA-3) in metastatic breast cancer.
"The acceptance of our application for review by the EMA represents a significant step towards potentially bringing Ibrance to women with metastatic breast cancer in Europe and Pfizer looks forward to working with the EMA on the review procedure," said Dr. Mace Thenberg, senior vice president of clinical development and medical affairs and chief medical officer for Pfizer ‘s oncology unit.
Ibrance’s revenue growth is becoming more pivotal to Pfizer. Pfizer’s revenues in developed markets grew $1.5 billion, with a big nod to "continued strong performance of several key products, notably Ibrance in the U.S," according to its second quarter report . Reuters pointed to Ibrance as contributing about half of Pfizer’s revenue growth during that period.
As Pfizer goes through the process of expanding its international market for Ibrance, other companies are beginning to gain ground in approvals for breast-cancer fighting drugs.
Novartis’ (CDK4/6) inhibitor ribociclib has been granted Breakthrough Therapy designation by the Food and Drug Administration in patients with advanced breast cancer, and is seen as a competitor to Ibrance. So is Eli Lilly & Co. own CDK 4/6 inhibitor ademaciclib, which the company has indicated it could file as soon as the third quarter.