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Breast cancer is a rare disease in humans, which prevents drug manufacturers from conducting clinical trials. But Pfizer has found a solution.
The giant of the pharmaceutical industry announced Thursday a new honor for the big seller Ibrance in men, relying largely on hard evidence. In the process, the regulators reviewed the electronic medical record and post-market reports from the IQVIA Insurance database, the Flatiron Health Breast Cancer database and Pfizer's own global database on HIV / AIDS. security.
The result? An FDA light for Ibrance, combined with an AstraZeneca aromatase inhibitor or Faslodex, for men with advanced or metastatic breast cancer with positive, HER2-negative HR. Invasive breast cancer will affect 2,670 men in 2019, according to Pfizer estimates.
"We are aware that our partnership with the FDA has allowed us to take a step forward in using real data to provide medication to the most needy patients," Chris Boshoff, MD, Ph.D., Chief Pfizer's developmental agent in oncology, said in a statement.
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Drug companies have been turning to real-world data for years to better justify their price decisions, but recently they have sought to use a real-world product's performance to better justify their new indications in the real world. regulatory authorities. In 2016, the 21st century treatment law laid the foundation for increased use of real world data in drug approval, and the new Ibrance sign reflects recent progress in this area.
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The move also gives Ibrance a new sales avenue – albeit limited – in an overcrowded area. Pfizer is counting on the drug to maintain its growth against the decline of its hit Lyrica, which will face generic competition in June. However, Novartis' Kisqali and Eli Lilly's Verzenio run after Ibrance after receiving FDA approval in 2017.
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