Recent Ibrance approval
On April 4, Pfizer (PFE) issued a press release announcing the FDA’s approval of its leading CDK4/6 (cyclin-dependent kinase 4/6) inhibitor therapy, Ibrance, for men suffering from HR-positive, HER2-negative metastatic breast cancer.
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According to Pfizer’s fourth-quarter earnings conference call, Ibrance has managed to maintain its leading position in the CDK4/6 inhibitor class of drugs for breast cancer in the United States due to multiple factors, such as the strength of its data, its first-mover advantage, and a favorable patient experience. The launch of Ibrance in the US market was the first phase of the drug’s growth strategy and included a focus on overall market growth of the CDK4 class of drugs as well as the rise of Ibrance as a leading player in the CDK4/6 inhibitor market.
According to Pfizer’s fourth-quarter earnings conference call, Ibrance currently accounts for 50% of the CDK-eligible patient population in the United States. The drug had been used to treat more than 95,000 metastatic breast cancer patients in the United States as of the end of 2018.
According to Pfizer’s fourth-quarter earnings conference call, for the second phase of the drug’s growth strategy, Pfizer has been focused on international market expansion for Ibrance since 2018. The drug has been launched in ex-US markets such as Europe, Japan, China, and Brazil, and it has managed to treat more than 85,000 metastatic breast cancer patients. The increasing penetration of Ibrance in developed Europe and Japan is expected to be a key growth driver for the drug in future quarters. According to Pfizer’s fourth-quarter earnings conference call, Ibrance has managed to secure reimbursement in the majority of developed ex-US markets and accounts for more than 90% of CDK 4/6 inhibitor market share by volume.
According to Pfizer’s fourth-quarter earnings conference call, for the third phase of the drug’s growth strategy, Pfizer is evaluating the potential of Ibrance in an adjuvant breast cancer setting in the PENELOPE-B and PALLAS trials, and it expects data readouts from these trials in 2020.
Pfizer is also involved in evaluating another CDK inhibitor therapy for metastatic breast cancer patients resistant to Ibrance.
To learn more about Ibrance’s revenue performances in the fourth quarter and 2018, read Pfizer: Ibrance and Xtandi Are Key Oncology Assets.