Pharmaand’s Rubraca Received EU’s CHMP Positive Opinion for the treatment of Ovarian Cancer
Shots:
- The EMA’s CHMP has adopted a positive opinion recommending approval of a Type II variation for Rubraca(rucaparib), as 1L maintenance treatment for all women with advanced ovarian cancer regardless of their BRCA mutation status, following frontline platinum-based CT. The EC’s decision is expected by YE 2023
- The opinion was based on the P-III ATHENA-MONO trial (NCT03522246) evaluating rucaparibmonotx,vs PBO in 538 women with newly diagnosed ovarian cancer showing improved investigator-assessed PFS and similar safety profiles for U.S. and European labels of rucaparib
- Rubraca is a PARP-1 inhibitor targeting the DNA repair mechanism in genetically mutated cancer cells, leading to cancer cell death & reduced tumor growth
Ref: Pharmaand | Image: Pharmaand
Related News:- Clovis Oncology Reports Results of Rubraca (rucaparib) in P-III ARIEL3 Study for Advanced Ovarian Cancer
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
