Drug Approval | December 21, 2024
USFDA approves Encorafenib plus Cetuximab and Chemo in BRAF V600E-positive mCRC
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
Harnessing advanced data analysis for early detection, prevention and better outcomes
First and only PARP inhibitor to improve overall survival in early breast cancer
Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
First patient enrolled in the Phase III SOHO-02 trial of investigational agent BAY 2927088 in treatment-naïve patients with advanced NSCLC with HER2-activating mutations
Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone
Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care
Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population
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