12. Piqray


Active ingredient: alpelisib
Disease: breast cancer
Peak sales estimate: n/a
Approved: May 27, 2019
Company: Novartis

The scoop: Novartis’ promise of 25 potential blockbuster launches is steadily coming to fruition. On the same day the FDA approved gene therapy Zolgensma, the U.S. regulator also waved through breast cancer drug Piqray. The drug boasts two firsts: One, it is the first drug meant specifically for HR+/HER2- breast cancer patients with a PIK3CA mutation. And it’s the first novel drug approved under the FDA’s Real-Time Oncology Review pilot program. Piqray could steal some share from Pfizer’s Ibrance and Eli Lilly’s Verzenio in second-line metastatic HR+/HER2- breast cancer. Now, with an FDA-approved diagnostic kit by Qiagen, doctors will be able to identify those with the PIK3CA mutation and will likely assign them to the Novartis drug. — Ben Adams

12. Piqray

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