Xtandi/Zytiga Combo Study Fails In Patients Previously Treated With Xtandi
A Phase IV study exploring Pfizer/Astellas’ Xtandi in combination with J&J’s Zytiga failed to increase progression-free survival in metastatic prostate cancer patients who progressed on Xtandi alone. Positive data would have been good news for Pfizer, which recently spent $14bn to gain Xtandi.
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Most of the $14bn value Pfizer agreed to pay to buy Medivation is tied to future growth of Xtandi, according to the company, but two pipeline assets and the potential to combine drugs could offer upside.
Medivation/Astellas’ Xtandi was approved barely a month after FDA announced it had accepted its NDA for post-chemo castration-resistant metastatic prostate cancer, and the newly approved androgen blocker appears to have what it takes to unseat J&J’s market leader Zytiga.
Marks appeared to use the variable EUA bar to justify what many viewed as early mistakes by FDA during COVID-19, and to emphasize the importance of physician awareness of the strength of evidence used to authorize a drug.