AstraZeneca and Merck & Co. were the first to grab an FDA approval for their PARP inhibitor Lynparza, and, despite growing competition, the drug is set to remain top dog in the PARP space.
That’s according to a new report out by analysts at GlobalData, which predicts $4 billion in global sales for Lynparza by 2027, boosted by new licenses.
Lynparza (olaparib) was first approved for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients who had already been given three lines or more of chemo back in 2014.
Since then, it has racked up supplemental U.S. nods in various cancers, including in certain breast, prostate, pancreatic and ovarian tumors.
GlobalData sees the drug’s revenues in these indications to reach “over 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.
It doesn’t have the market to itself, however, with GSK’s PARP inhibitor Zejula (niraparib) holding the second position, with more than $1.6 billion in sales and 28% of the market share.
The drug, which was originally developed by Tesaro before being bought out by GSK, saw its 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 PARPs, however. AZ and Merck back in the fall of 2022 voluntarily pulled the drug from treating 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 its drug Rubraca, had also pulled their drugs in the same patient population. Rubraca has seen the hardest path, with Clovis a year back selling 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.
For Lynparza and Zejula, however, the withdrawals did not cause much of a sales impact, given that the drugs have largely moved into earlier treatment settings.
And, while Lynparza will 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 is hope on 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.”
AZ is also working on an experimental selective PARP1 inhibitor, saruparib, which has shown some early promise in phase 1/2 trials for homologous recombination repair (HRR)-deficient advanced breast cancers.
“If approved, saruparib would further strengthen AstraZeneca’s lead in the PARP inhibitor market,” Podder said.