Pfizer TALZENNA XTANDI Approval: FDA Clears Combination for an Earlier Metastatic Prostate Cancer Setting

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The FDA has expanded the TALZENNA XTANDI approval to men with HRR gene-mutated metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. The decision rests on Phase 3 TALAPRO-3 data showing an estimated 52% reduction in the risk of radiographic progression or death.

Pfizer TUKYSA FDA Approval: Chemotherapy-Free Front-Line Maintenance Now Available for HER2+ Metastatic Breast Cancer

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The FDA has approved Tecentriq and Tecentriq Hybreza with a fluoropyrimidine and oxaliplatin for adjuvant treatment of stage III dMMR colon cancer, based on the phase III ATOMIC trial.

Pfizer and Astellas Win FDA Approval for PADCEV Plus Keytruda in Muscle-Invasive Bladder Cancer

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The FDA has approved PADCEV plus Keytruda as the first platinum-free neoadjuvant and adjuvant regimen for adults with muscle-invasive bladder cancer, regardless of cisplatin eligibility, backed by Phase 3 EV-304 data showing major reductions in recurrence and death risk.

Pfizer Inc. Announces Milestone as FDA Approves Pfizer’s Ibrance Regimen for Advanced Breast Cancer Frontline Maintenance

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Pfizer Inc. announced the landmark FDA expansion of IBRANCE (palbociclib) in combination with anti-HER2 and endocrine therapies for HR+, HER2+ metastatic breast cancer frontline maintenance following successful Phase 3 PATINA trial results.