May 10, 2018 Source: drugdu 148
With a view to widening the scope of treatment for ovarian cancer patients, EU regulators have greenlighted MSD’s Lynparza and stamped approval for a new dosing regimen and tablet formulation for AstraZeneca.
Regardless of BRCA status, clearance has been issued for Lynparza (olaparib) tablets as a form of maintenance therapy for patients suffering from primary peritoneal cancer or high-grade platinum-sensitive relapsed (PSR), epithelial ovarian, fallopian tube cancer with the patients having registered partial response or complete response to platinum-based chemotherapy. The original approval for the drug was given in capsule form in Europe 2015. However, the approval was limited only for one in five woman cancer sufferers also afflicted with the BRCA mutation.
Lynparza’s patient outreach is expected to show a significant improvement in the approval of the tablets for all patients with high-grade PSR ovarian cancer, notwithstanding the BRCA status.
European regulators have approved a tablet formulation and new dosing regimen for AstraZeneca and MSD’s Lynparza to treat a wider range of patients with ovarian cancer. Two randomized trials, SOLO-2 and Study 19 formed the foundation for rolling out the clearance by demonstrating that as compared to placebo, the therapy reduced the disease progression risk or death threat for PRS ovarian cancer patients significantly by 70 percent and 65 percent respectively.
A newly approved dosage schedule by EU regulators prescribes a reduction in daily pill intake from eight pills daily to two pills daily with or without consumption of food.By Ddu
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