More Good News For AML As Pfizer And AbbVie/Roche Drugs Get FDA Okay
The options for AML are on the rise after no drugs for decades and the green lights for Daurismo and Venclexta mean that seven therapies for the disease have now been approved by the FDA since 2017.
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Weeks after their first combo study with Venclexta in first-line AML failed, AbbVie and Genentech reported top-line data showing that the BCL-2 inhibitor plus azacitidine improved survival and remission rates.
AbbVie’s Venclexta failed to show a significant improvement in the primary endpoint of overall survival in the Phase III VIALE-C for AML, but there was numerical improvement. Its setback is good news for Pfizer’s rival Daurismo, analysts said.
Rigel Pharmaceuticals and Jazz Pharmaceuticals are among the companies that could find out this week whether their new drug applications at the European Medicines Agency are likely to be approved for marketing across the EU. The EMA's key scientific committee, the CHMP, will also consider applications from Roche and Novartis.