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Latest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissions

With 5.6 months of additional follow-up and 78.3% of patients having completed Kisqali® (ribociclib) investigational treatment, the updated analysis shows. ....

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FDA Offers Priority Review to Enfortumab Vedotin-Ejfv, Pembrolizumab Combination for Metastatic Bladder Cancer

If approved, this combination will become a first-line treatment option for patients who are cisplatin eligible. ....

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FDA Grants Priority Review to sBLA for Enfortumab Vedotin Plus Pembrolizumab in Advanced Urothelial Cancer

The FDA has granted priority review to a supplemental biologics license application for enfortumab vedotin plus pembrolizumab for the frontline treatment of patients with locally advanced or metastatic urothelial cancer. ....

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FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

/PRNewswire/ Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Seagen Inc. (Nasdaq: SGEN) today announced that on November. ....

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Seagen (SGEN) Announces FDA Grants Priority Review for sBLA of PADCEV with KEYTRUDA for First-Line Treatment of Advanced Bladder Cancer

Seagen (SGEN) Announces FDA Grants Priority Review for sBLA of PADCEV with KEYTRUDA for First-Line Treatment of Advanced Bladder Cancer
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