Welcome To Welox Pharma WHO-GMP | ISO 9001:2015
Translated into:
Welcome To Welox Pharma WHO-GMP | ISO 9001:2015
Introduction to Lynpraza Tablet:
Trailblazing Ovarian Cancer Therapy Lynparza Tablet, featuring olaparib and championed by AstraZeneca, signifies a groundbreaking advancement as the premier PARP inhibitor medication sanctioned for advanced ovarian cancer with germline BRCA mutations.
FDA Approval: A Decisive Breakthrough
In a monumental stride, the US Food and Drug Administration (FDA) granted approval to Lynparza (olaparib) in December 2014. This marked a significant milestone as it became the first monotherapy endorsed for patients grappling with malignant germline BRCA-mutated advanced ovarian cancer. This approval is particularly significant for individuals who have undergone three or more prior lines of chemotherapy treatment.
Accelerated Approval and Ongoing Trials:
A Dual Commitment Lynparza earned accelerated approval from the FDA based on compelling results from Phase II clinical trials. Simultaneously, Phase III trials are actively underway, promising further validation of clinical benefits. Subsequent approvals hinge on the confirmation of these advantages.
European Commission's Stamp of Approval:
Extending Reach The European Commission (EC) mirrored the FDA's endorsement, granting marketing authorization to Lynparza in December 2014. It earned accolades as the inaugural maintenance therapy for adults contending with platinum-sensitive relapsed BRCA-mutated high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This approval extends across the European Union member states, as well as Norway, Iceland, and Liechtenstein.
Ongoing Strides Against Ovarian Cancer:
AstraZeneca's Commitment AstraZeneca, unwavering in its commitment, submitted a modified new drug application (NDA) in July 2014, responding to the FDA's request for additional data. This followed the initial NDA submission in February 2014.