AstraZeneca oldie Faslodex nets another breast cancer approval

AstraZeneca's Faslodex won its first approval back in 2002.

AstraZeneca may have recently hit a snag in the immuno-oncology space, but it got a boost Monday elsewhere in its cancer portfolio.

The FDA expanded use of Faslodex, granting AZ an indication for solo use in HR+, HER2- breast cancer patients who haven’t been previously treated with endocrine therapy. And the green light means “more patients can have the opportunity to receive Faslodex earlier in the treatment journey,” Jamie Freedman, EVP and head of the company’s oncology business unit, said in a statement.

The approval comes after Faslodex showed it could beat out fellow AZ med Arimidex at delaying the time until patients’ disease progressed. In a phase 3 study, Faslodex held disease at bay for a median 16.6 months, trumping Arimidex’s 13.8-month mark.


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RELATED: AZ stokes $45B sales hopes with expanded approval for breast cancer drug Faslodex

Faslodex isn’t exactly new on the scene. It’s been around since 2002 when it won its other monotherapy approval, for the treatment of postmenopausal women with HR+ breast cancer whose cancer had progressed after antiestrogen therapy. Its more recent green light, though, came last year, in tandem with Pfizer blockbuster Ibrance for HR+, HER2- breast cancer patients who had seen their cancer worsen after endocrine therapy.

While the company doesn’t count the med among its growth products, sales of Faslodex contributed to a $3.38 billion oncology haul in 2016, a portfoliowide tally that comprised 16% of the company’s top-line total for the year.

RELATED: AstraZeneca's Mystic shortfall is an immuno-oncology shake-up for Bristol-Myers and a bolster for Merck and Roche

Meanwhile, AstraZeneca has run into trouble trying to run that revenue mark skyward; last month, it announced that a pairing of immuno-oncology med Imfinzi and candidate tremelimumab had missed the mark in a lung cancer trial, failing to stave off lung cancer progression better than chemotherapy or Imfinzi alone.

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