Afinitor recommended in Europe for breast cancer
pharmafile | June 22, 2012 | News story | Sales and Marketing | Afinitor, CHMP, Cancer, Novartis, breast
A European committee is recommending Novartis’ Afinitor to treat women with a certain type of breast cancer.
The CHMP says that Afinitor should have a new licence for the treatment of hormone receptor-positive, HER2 negative advanced breast cancer.
The indication is specifically designed to be used in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
The final decision as to whether it will receive this licence now rests with the European Commission – it will publish its conclusion within the next three months.
Hervé Hoppenot, president of Novartis Oncology, said: “Afinitor represents the first major innovation in HR+/HER2- advanced breast cancer since aromatase inhibitors were introduced more than 15 years ago.
“The Committee’s support of Afinitor brings us one step closer to providing an important new option for women living with this disease.”
The recommendation is based on recent data from BOLERO-2, a Phase III study of postmenopausal women with oestrogen-receptor positive advanced breast cancer who tested negative for HER2.
This study found that Afinitor plus exemestane, a hormonal therapy, more than doubled the time women lived without cancer growth compared to exemestane alone (6.9 versus 2.9 months).
The drug is already approved by the European Medicines Agency to treat advanced pancreatic neuroendocrine tumours and advanced renal cell carcinoma after treatment with a VEGF inhibitor.
Afinitor is currently being considered for this licence by the FDA and several other markets. The drug brought in just under $300 million last year, but this new licence could see it reach blockbuster status.
Deutsche Bank analyst Tim Race said he expects global peak annual sales for Afinitor to reach $1.7 billion in breast cancer alone.
Novartis is also studying the drug for use in patients with HER2-positive breast cancer in two late-stage trials, meaning it could further increase its sales.
Ben Adams
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