PharmiWeb Today Story
Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression or death by 50% vs. Faslodex standard of care in a biomarker-altered population
AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been recommended for approval in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the CAPItello-291 Phase III trial published in The New England Journal of Medicine.1
In the trial, Truqap in combination with Faslodex reduced the risk of disease progression or death by 50% versus Faslodex alone in patients with tumours harbouring PI3K, AKT or PTEN alterations (based on hazard ratio of 0.50, 95% confidence interval 0.38-0.65; p=<0.001; median progression-free survival (PFS) 7.3 versus 3.1 months).1
In Europe, breast cancer remains the leading cause of cancer death, with more than 140,000 deaths in 2022 and more than 550,000 new patients diagnosed in the same year.2 HR-positive breast cancer (expressing estrogen or progesterone receptors, or both), is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-low or HE…
Read More...Articles
What Does a Clinical SAS Programmer Do?
16-Apr-2024
The Evolution of Clinical Data Management
10-Apr-2024
9 Clinical Data Management Career Paths
08-Apr-2024
Featured Events
-
Pharmaceutical Manufacturing & Packaging Congress…
28-Jun-2021 - 29-Jun-2021 -
HFpEF Drug Discovery & Development Summit 2022
25-Jan-2022 - 27-Jan-2022 -
Pharma USA 2022
16-Mar-2022 - 17-Mar-2022 -
Pharmaceutical Manufacturing and Packaging Congres…
20-Jun-2022 - 21-Jun-2022 -
PM Society: Measuring Patient Engagement: Opening…
12-Oct-2022 - 12-Oct-2022 -
How to impact, influence & inspire
07-Feb-2023 - 21-Feb-2023
News
-
FREmedica Partners With CellCore at ECO24
29-Apr-2024 -
Napo Pharmaceuticals, a Jaguar Health Family Compa…
29-Apr-2024 -
Hypha Labs Names Craig Ellins Chief Science Office…
29-Apr-2024 -
Specialty Revenue Cycle Management Firms Revolutio…
29-Apr-2024 -
Gerresheimer partners with RxCap to offer connecte…
29-Apr-2024 -
Mosaic ImmunoEngineering Agrees to Acquire Clinica…
29-Apr-2024