Drug ApprovalAcquisitionPhase 3Phase 1Clinical Result
AstraZeneca also has a new PARP inhibitor in early trials that could help boost future lagging sales from Lynparza when it starts to lose patent protection in 2028.
AstraZeneca and Merck & Co.PARPe the first to grab an FDA approval for their PARP inhibitor Lynparza, and,Lynparza growing competition, the drug is set to remain top dog in the PARP space.
Lynparza (olaparib) was first approved for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer Lynparza who had already been given three lines or more of chemo back in 2014.
GlobalData sees the drug’s revenues in these indications to reacancersr 68% of the global PARP inhibitors market by 2027,” helping bring in that $4 billion. Most of Lynparza's sales come from ovarian and HER2-negative breast cancer treatment, the analysts said in their latest report.
The drug, which was originally developed by Tesaro bGSKre PARP inhibitor ZejulaPARPg bought out by GSKniraparib first approval in 2017 for ovarian cancer. It has since added several new licenses within that disease space.
It’s not all been positive for Lynparza and Tesaro however. AZ and Merck back GSKthe fall of 2022 voluntarily pulled tovarian cancerreating heavily pretreated ovarian cancer patients, after seeing a potential “detrimental effect” on patient survival from a confirmatory phase 3 trial.
GSK and Clovis Oncology, for itLynparzaubraca, had also pulled theiMerckgs in the same patient population. Rubraca has seen the hardest path, with Clovis a yeaovarian cancer off the PARP drug in a bankruptcy sale to a Swiss pharma. The drug never really picked up after its approval in 2016 and has been the weak link in the PARP market.
And,LynparzaynparZejulal be making strong blockbuster sales in 2027, patent protection in the U.S. falls off in 2028. From then on, “there is an anticipated downshift in sales post-patent expiry through generic erosion,” said Biswajit Podder, Ph.D., oncology and hematology analyst at GlobalData.
But there iLynparzan the horizon. Lynparza currently has 123 ongoing phase clinical trials across a multitude of cancer types and combos, which GlobalData says “signifies its pivotal role in oncology.”oncology
AZ is also working on an experimenLynparzactive PARP1 inhibitor, saruparib, which has shown some early promise incancer 1/2 trials for homologous recombination repair (HRR)-deficient advancedoncologycancers.
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