The Pharma Data

MARCH 25, 2021

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

HR Clinical Trials Clinical Trials Trials 52

The Pharma Data

MARCH 25, 2021

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.

Genotoxicity 52

Genotoxicity Genotype Containment Protein 52

The Pharma Data

APRIL 7, 2021

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

HR Genotype FDA Approval Genotoxicity 52