Where were you when...?
On this date, the FDA made it official — T-DXd was approved for HER2-low AND ultralow HR+ mBC, and the team's collective blood pressure finally dropped."
What is January 27, 2025?
This LRR1 strategist kept AZ's DB-06 Launch Readiness on track before passing the torch
Who is Alex Schuster?
This staining technique used to measure HER2 protein expression on the surface of tumor cells shares its name with this acronym.
This new biotech is looking to claim the HR+ with their new PIK3CA inhibitor
What is Celcuity?
The median PFS for T-DXd in DB-06 — a number the team has said out loud approximately 10,000 times.
What is 13.2?
NCCN guidelines updated on this date
What is January 31, 2025?
She led AZ's diagnostics strategy for LRR 1 & 2, ensuring the HER2-Ultralow testing story was ready for prime time
Who is Natalie Todd?
This molecular test — whose name references a glowing detection method — confirms whether HER2 gene amplification is present
What is FISH?
This TROP2 ADC showed up to the party, tried to claim the HR+ mBC dance floor, and got sent home early
What is Trodelvy
The median PFS for the TPC arm — the number that makes 13.2 months matter.
What is 8.1 months?
The joint DS/AZ team crossed the elusive LRR2 threshold together on this date
What is November 22, 2024?
This DS lead shepherded LRR2 for DB-06, bridging the science and execution
Who is Danqing Yu?
The comprehensive definition of HER2-low: IHC score and ISH status.
What is IHC 1+ or IHC 2+/FISH-?
Their ADC isn't expected until 2027 — but their founders didn't wait around to find out, departing earlier this year.
What is BNT-323 or BIOnTech?
The hazard ratio for PFS in DB-06 — the stat that made this a practice-changer
What is 0.62?
"Fresh off the TLR, the team regrouped on this September date to figure out what the data meant for strategy
What is September 20, 2024?
Who is Aliya Omer?
This HER2 expression category — IHC 0 with any membrane staining — was validated for T-DXd benefit for the first time in DB-06.
What is HER2-Ultralow?
TROP2-directed ADC — same alliance, different target, different payload
What is DATROWAY?
The T-DXd dose used in DB-06, the same approved across the DESTINY-Breast program.
What is 5.4mg/kg?
On this March date, pathologists everywhere got new marching orders — the CAP updated its reporting template to distinguish IHC 0 with membrane staining.
What is March 19, 2025?
The former head of US business at DS, he set the commercial vision
Who is Dan Switzer?
ngOral serds are using this type of testing to identify ESR1m status
What is ctDNA testing?
This PI3K inhibitor extended the ET era for PIK3CA-mutated patients — keeping them out of the ADC lane a little longer.
The percentage of the HR+ mBC population estimated to be HER2-low or ultralow — the number that reframes how big this opportunity actually is.
What is 80%?