European Medicines Agency
Breast cancer drug that extends life given nod by European regulator
The European Medicines Agency has recommended palbociclib for approval for use with an aromatase inhibitor or with fulvestrant in post-menopausal women.
Source: Zephyr / Science Photo Library
A new breast cancer drug that could delay the progression of the disease for an extra ten months has been recommended for approval by the European Medicines Agency (EMA).
Palbociclib, marketed as Ibrance by Pfizer, has the ability to halt breast cancer’s progress in some post-menopausal women when given as a combination therapy — double the length of time compared with other treatments.
The product is the first cyclin-dependent kinase 4/6 (CDK4/6) inhibitor to be recommended for use in the EU; it was recommended by the US Food and Drug administration in February 2016.
The EMA says that palbociclib should be marketed for use in post-menopausal women with hormone receptor positive and human epidermal growth factor receptor 2 (HER2)-negative locally advanced breast cancer.
It should be given in combination with an aromatase inhibitor or with fulvestrant in patients who have had prior hormone therapy. For pre-menopausal women the agency says that hormone therapy should be combined with a luteinising hormone releasing hormone (LHRH).
The EMA’s recommendation follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), which was based on the results of two phase III trials.
One study involved women who were given palbociclib and the aromatase inhibitor letrozole or letrozole alone. The cancer’s progress was halted for an average 24.8 months in the 444 women who received palbociclib with letrozole, compared with an average of 14.5 months in the group of 222 patients that received letrozole on its own.
The second trial compared fulvestrant plus palbociclib with fulvestrant on its own and included 521 pre and post-menopausal women. Preliminary results have shown that 347 women given the combination treatment had an average of 11.2 months without their disease getting worse, compared with 4.6 months for the 174 women given fulvestrant alone.
Mia Rosenblatt, assistant director of policy and campaigns at the patient charity Breast Cancer Now, says palbociclib has “significant potential” and the charity is “excited” by the EMA’s decision.
“It’s a first-in-class drug that can stop patients’ breast cancers progressing for an extra ten months on average compared to current treatments, time that could be truly invaluable to patients.”
But Rosenblatt is pessimistic that the drug will be made available on the NHS to women in the UK if the European Commission approves the recommendation.
“We haven’t seen a single example of the current National Institute for Health and Care Excellence appraisal system working for new breast cancer drugs in the last seven years and, without reform, we’re not any more optimistic for palbociclib,” she says.
David Montgomery, medical director for oncology at Pfizer, which manufactures the drug, says: “This [product] will represent an important step toward expanding treatment options for women with the most common type of advanced breast cancer.”
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20201743
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