Remove Genotoxicity Remove Hormones Remove Marketing
article thumbnail

FIRST-LINE IBRANCE® (PALBOCICLIB) COMBINATION THERAPY IN HR+, HER2- METASTATIC BREAST CANCER

The Pharma Data

Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1%

HR 52
article thumbnail

Treatment of Metastatic Triple-Negative Breast Cancer

The Pharma Data

The validation of our EU marketing application is an important step toward addressing the significant unmet medical need for people with metastatic triple-negative breast cancer.”. including final safety information for prescribers) will be assessed as part of ongoing and future Marketing Authorization Applications.

article thumbnail

Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

The Pharma Data

The European Medicines Agency has also validated a Marketing Authorization Application for Trodelvy in the European Union. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. All filings are based on data from the Phase 3 ASCENT study. Trodelvy Boxed Warning. The Trodelvy U.S.

HR 52