Based on the numbers this would be on par for FDA approval which...

Based on the numbers this would be on par for FDA approval which if numbers continue in Ph3 would likely be approved as a therapy. This strategy looks like PTX will not settle until they have explored FIrst in line - ie blockbuster potential. These results already look to be on track to exceed or match recent FDA approved second line therapies eg in AML. IMO the addition of a trial combining with hormone therapy is because the team are aiming for blockbuster first in line therapy results aka - https://endpts.com/why-wait-the-fda-stamps-an-ultra-fast-ok-on-a-her2-drug-expected-to-create-astrazenecas-next-blockbuster-franchise/

this strategy is better for patients