Erika Hamilton, Chief Development Officer, Late Phase and Director, Breast Cancer Research Program at Sarah Cannon Research Institute, shared on LinkedIn:
“Ten.
That’s how many new FDA-approved indications breast cancer gained in 2026 – and every one of them landed between May 1 and September 18.
That’s 10 new therapies for patients in 5 months.
10 indications across 8 approval actions.
3 were first-ever approvals of a new drug (vepdegestrant, camizestrant, gedatolisb).
3 of them were firsts in a deeper sense:
- Vepdegestrant – the first PROTAC approved in any cancer. A new modality, not just a new molecule.
- Palbociclib + trastuzumab – the first CDK4/6 inhibitor to reach HER2-positive disease.
- Camizestrant – the first therapy approved on a resistance mutation found in ctDNA *before* a scan shows progression.
ESR1 alone drove three separate approvals this year, two of them fourteen days apart.
And T-DXd crossed into curative intent – both neoadjuvant and adjuvant – for the first time.
We have been fortunate at Sarah Cannon Research Institute across our network and in my clinic SCRI Oncology Partners to work on many of these approvals. We should also give credit to the FDA, this is an immense amount of data and work and breast oncology is certainly not the only oncology approvals they are sorting through when they are already understaffed.
So many people behind these results from patients, caregivers, pharma, investigators, nurses, site trial staff, regulators, to all advance care so dramatically in 2026.
10 approvals in 5 months emphasizes to me the pace of progress in bcsm. It also underscores the importance of clinical trials. The importance of clinical trials to advance care, and also the importance of each individual patient understanding that a clinical trial may be an option for them…now!”
You can also read ‘FDA Approves Imlunestrant Plus Abemaciclib for ESR1-Mutated Advanced Breast Cancer After Endocrine Therapy‘
