The drugmaker will promote Zejula without a biomarker as a first-line maintenance option, and Myriad will highlight that patients with HRD are most likely to benefit.
Myriad filed an sPMA for myChoice CDx despite GSK's confidence that Zejula will be approved in newly diagnosed ovarian cancer regardless of biomarker status.
For heavily pretreated ovarian cancer patients, doctors will now have to weigh their HRD status in the context of an increasingly complex backdrop of biomarker information.
Researchers measured proteins produced by 193 deletions in 136 CRISPR-deleted genes and found residual protein expression in roughly one-third of these cases.
The drug is now approved as a fourth-line option for advanced, fallopian tube, or primary peritoneal cancer patients who have homologous recombination deficiency.
