EMA：Pfizer 撤回 Ibrance 用于 HR 阳性、HER2 阳性乳腺癌维持治疗的申请

Overview

Pfizer Europe MA EEIG withdrew its application to extend the use of Ibrance to the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer.

The Company withdrew the application on 15 September 2026.

Ibrance is a cancer medicine used to treat breast cancer when the cancer is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). Ibrance can only be used when the cancer cells have receptors (targets) for certain hormones on their surface (HR-positive) and do not produce abnormally large quantities of a receptor called HER2 (HER2-negative). Ibrance is used in the following ways:

together with an aromatase inhibitor (a hormonal cancer medicine);
together with fulvestrant (another hormonal cancer medicine) in patients who have previously been treated with a hormonal medicine.

In women who have not gone through menopause, a medicine called a luteinising hormone-releasing hormone agonist should also be given.

Ibrance has been authorised in the EU since 2016. It contains the active substance palbociclib and is available as capsules and tablets.

The company applied to extend the use of Ibrance to the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer. Ibrance was intended to be used in combination with medicines that block HER2 and endocrine (hormonal) therapies following an initial treatment to bring the cancer under control (induction treatment).

In the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer, Ibrance was expected to work in the same way as it does in its existing uses. The active substance in Ibrance, palbociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which play a key role in regulating the way cells grow and divide. In some cancers, including HR-positive breast cancer, the activity of CDK 4 and 6 is increased, which helps the cancer cells to multiply uncontrollably. By blocking CDK4 and CDK6, Ibrance slows the growth of HR-positive breast cancer cells.

The company presented results from one main study involving 518 adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer who had all received initial treatment with chemotherapy and medicines that block HER2.

As maintenance treatment, patients received either Ibrance together with medicines that block HER2 and endocrine therapy or the same treatment without Ibrance. The main measure of effectiveness was how long patients lived without their disease getting worse. The study also looked at how long patients lived overall.

The application was withdrawn after the European Medicines Agency had evaluated the information from the company and had prepared questions for the company. After the Agency had assessed the company’s responses to the questions, there were still some unresolved issues.

At the time of the withdrawal, based on its review of the information and the company’s response to its questions, the Agency had concerns and its provisional opinion was that the change to Ibrance’s marketing authorisation could not have been authorised.

The Agency considered that the study did not provide sufficiently reliable evidence that Ibrance was effective in the proposed use. The study was open-label, meaning that the patients and the doctors carrying out the study knew which treatment was being given. The main assessment of whether the cancer had worsened was made by these doctors, and differences between their assessments and an independent review of the scans raised concerns that the results may have been biased in favour of Ibrance. The independent review did not confirm a clear improvement, and the other measures of effectiveness did not provide sufficient supporting evidence.

Therefore, at the time of the withdrawal, the Agency’s opinion was that the benefits of Ibrance in the maintenance treatment of HR-positive, HER2-positive locally advanced or metastatic breast cancer had not been demonstrated.

In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal was to allow for additional data collection and analyses to address the questions raised by the Agency.

The company informed the Agency that there are no consequences for patients in clinical trials receiving Ibrance.

If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.

There are no consequences for Ibrance in its authorised uses.

Key facts

Name of medicine: Ibrance
EMA product number: EMEA/H/C/003853
Active substance: Palbociclib
International non-proprietary name (INN) or common name: palbociclib
Therapeutic area (MeSH): Breast Neoplasms
Anatomical therapeutical chemical (ATC) code: L01EF01
Marketing authorisation holder: Pfizer Europe MA EEIG
Date of issue of marketing authorisation valid throughout the European Union: 09/11/2016
Date of withdrawal

More information on Ibrance

Ibrance

This page was last updated on 28/10/2026