Pfizer gets early approval for breast cancer drug
pharmafile | February 4, 2015 | News story | Sales and Marketing | FDA, Pfizer, Xalkori (crizotinib), axitinib, bosulif, bosutinib, femara, ibrance, inlyta, letrozole, palbociclib
The FDA has shown Pfizer’s breast cancer drug Ibrance an early green light to treat patients who are at the advanced stages of the disease.
Ibrance (palbociclib) has been given accelerated approval based on its progression-free survival (PFS), and Pfizer will be pinning its hopes of financial recovery on such drugs after it recently reported an overall 2014 revenue decrease of $2 billion.
Pfizer’s Ibrance is for postmenopausal women with metastatic breast cancer whose disease responds to estrogen receptors, a group of proteins found inside cells. It is to be used in combination with Femara (letrozole) – a treatment for breast cancer patients after surgery and for ovarian stimulation.
“Metastatic breast cancer patients represent a community that is in great need of more meaningful advances and options in the treatment of metastatic disease,” comments Shirley Mertz, who is the president at Metastatic Breast Cancer Network.
“The approval of Ibrance represents a major step forward. We are thankful that this important medicine is now widely available to patients.”
The novel drug works by deterring cyclin-dependent kinases (CDKs) enzymes four and six, which are key regulators of the cell cycle which trigger cellular progression.
Approval was based on the results of a Phase II trial which achieved its primary endpoint by demonstrating that by combining Ibrance with Femera – prolonged PFS compared with using Femera alone.
According to an analyst at Leerink the drug is estimated to generate sales of between $3-5 billion in 2020.
Pfizer’s chairman and chief executive Ian Read explains: “Ibrance in combination with letrozole almost doubled the time before tumour progression, delaying the need for later-line therapies including other hormonal agents and chemotherapies.”
Oncology has been a crucial growth area for Pfizer, highlighted by a number of cancer drug approvals over the last few years including Xalkori (crizotinib), Inlyta (axitinib) and Bosulif (bosutinib) for leukaemia.
According to the World Health Organization, breast cancer is the most common form of the disease among women worldwide, claiming the lives of hundreds of thousands each year.
It affects one in eight females in the UK where around 55,000 people are diagnosed each year. In the US in 2013 alone, 232,340 cases of invasive breast cancer were diagnosed in women, and of those 39,630 died.
This early approval from the FDA puts Pfizer slightly ahead of other pharma firms also aiming to enter the CDK inhibitors market, such as Novartis’ own offering Lee011, plus Eli Lilly’s abemaciclib currently in Phase III.
Tom Robinson
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