CDK4/6 inhibitors remain the standard treatment for advanced and metastatic HR+/HER2- patients. We expect their uptake to increase significantly over the forecast period as Verzenio and Kisqali are projected to receive strategic label expansions into the adjuvant treatment setting for early-stage HR+/HER2- breast cancer patients. Verzenio was the first of these therapies to be approved in early breast cancer in the US (in October 2021), with EMA approval being granted in April 2022. Submissions were based on positive results from the Phase III monarchE trial. Ibrance is not forecasted to receive a similar approval after the failure of the PALLAS and PENELOPE-B trials. 

PARP inhibitors have become the standard option for germline BRCA1/2-mutated (gBRCAm) breast cancer patients. Despite their efficacy in this population, their overall commercial potential will remain limited in the near term by their positioning in this niche segment. Expansion into the adjuvant setting for earlier-stage disease will improve their outlook, beginning with Lynparza, which improved the risk of invasive breast cancer recurrence, second cancer, or death by 42% over placebo in the Phase III OlympiA trial, resulting in approval for this patient segmentation. 

This Datamonitor Healthcare report contains a Disease Analysis module.