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Pfizer keeps nose ahead of rivals with new Ibrance approval

FDA licenses new indication for the breast cancer treatment

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Pfizer's CDK4/6 inhibitor Ibrance is facing its first competition in the marketplace, but the company has hit back with a new approval broadening its label.

The US FDA has converted its earlier conditional approval of Ibrance (palbociclib) into full approval as a first-line treatment of post-menopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

That labelling allowed the drug to be used in combination with Novartis' aromatase inhibitor Femara (letrozole), but the US regulator has now said Ibrance can also be used alongside any aromatase inhibitor - a class which also includes AstraZeneca's Arimidex (anastrozole) and Pfizer's own Aromasin (exemestane) brand as well as generics.

The new approval comes on the back of the confirmatory PALOMA-2 trial, which showed that adding Ibrance to aromatase inhibitor therapy in significantly extended progression-free survival (PFS) compared to placebo. The median PFS of the Ibrance plus letrozole combination exceeded two years - the first treatment for this population of women to achieve that objective in a Phase III study.

That broadening of the label keeps Ibrance ahead of its main CDK4/6 inhibitor rival - Novartis' Kisqali (ribociclib) - which was approved last month for first-line HR+/HER2- breast cancer therapy in combination with letrozole only. Also approaching the market is Eli Lilly's abemaciclib, which is in late-stage development.

Ibrance is also approved as a second-line therapy alongside oestrogen receptor antagonist fulvestrant in women whose disease has progressed despite earlier endocrine therapy.

Liz Barrett, global president and general manager at Pfizer Oncology, said: "In the two years since its initial approval, Ibrance has been prescribed to more than 50,000 patients by more than 9,800 physicians in the US.

"This important update to the Ibrance label underscores the strength of the data we continue to generate for Ibrance."

EvaluatePharma analysts have suggested Ibrance will become a mega-blockbuster with sales of $6bn-plus in 2022, consigning its CDK4/6/rivals - still tipped for big sales - into a scrabble for second place.

Article by
Phil Taylor

3rd April 2017

From: Regulatory

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