Novartis wins U.S. approval for breast cancer drug; to compete with Pfizer’s Ibrance

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By John Miller | ZURICH

ZURICH Novartis has won U.S. Food and
Drug Administration approval for Kisqali to treat postmenopausal
women who have a difficult-to-treat form of breast cancer,
challenging U.S. rival Pfizer’s Ibrance.

The Swiss company has priced Kisqali to be cheaper than
Ibrance, which analysts said could help it win business, though
Kisqali’s approval includes additional patient monitoring
requirements that could work against the new drug.

Novartis considers Kisqali to be one of its stable of 13 new
medicines with blockbuster potential for annual revenue in the
billions of dollars. Analysts see global annual sales reaching
$1.5 billion by 2022, Thomson Reuters data shows.

British biotech company Astex Pharmaceuticals, now part of
Otsuka, will receive undisclosed payments from
Novartis, having worked out the structure of the key protein
targeted by Kisqali.

Approval for Kisqali, previously known as LEE011 and to be
administered in combination with letrozole, is for first-line
treatment of hormone receptor positive, human epidermal growth
factor receptor-2 negative (HR+/HER2-) advanced or metastatic
breast cancer, Novartis said late on Monday.

The quick U.S. approval provides Novartis with the jump-off
point to challenge Pfizer’s Ibrance in the initial treatment of

Ibrance hit about $2.1 billion in sales in 2016.

Novartis estimates that it has priced Kisqali at an 18-20
percent discount to Ibrance while providing for flexible dosing.

Leerink analyst Seamus Fernandez said in a note that the
pricing could help to drive take-up for prescriptions but that
cost factors could be outweighed by patient monitoring
requirements that are more rigorous than those for Ibrance.

Kisqali comes with warnings for so-called QT prolongation,
which can signal heart problems and liver issues.

“Physicians will likely find the monitoring requirements
associated with Kisqali to be burdensome relative to Ibrance,”
Fernandez wrote.

Novartis said that no head-to-head studies of Kisqali and
Ibrance had been done, making efficacy and safety comparisons
impossible. But the company said that most health issues that
arose during Kisqali’s trials were mild to moderate and
generally managed through interrupting or reducing the dose.

Kisqali plus letrozole reduced the risk of disease
progression or death by 44 percent over letrozole alone,
according to results of a study released last year.

The Novartis drug is also under review in Europe. (Additional reporting by Ben Hirschler)

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