BioCentury This Week Ep. 350 - Oral SERD Spotlight. Plus: Setbacks at FDA
9 snips
Feb 17, 2026 Lauren Martz, product development lead covering oncology and targeted therapies, breaks down why oral SERDs are a catalyst-rich approach for ER+ HER2- breast cancer. Steve Usdin, Washington regulatory analyst, reviews recent FDA setbacks including a Moderna refusal to file and a CRL to Disc Medicine and calls for accountability at CBER. Short, focused takes on trial positioning, competitive mechanisms, and regulatory fallout.
AI Snips
Chapters
Transcript
Episode notes
Oral SERDs Target A Massive Breast Cancer Market
- Oral SERDs target a huge market because ~70% of breast cancers are ER-positive and can be chronic indications.
- Next-gen oral SERDs could replace fulvestrant by offering oral dosing and potential brain metastasis activity.
Regulatory Milestones Could Validate Degraders
- Vepdegestrant's potential approval is a milestone for both oral SERDs and the targeted protein degradation field.
- A first PROTAC approval could occur in 2026, validating the modality beyond estrogen receptor targets.
Degradation Offers Broader Pathway Blockade
- Degraders can block nearly all ER signaling by knocking down the receptor and adding antagonistic activity.
- PROTACs and oral SERDs differ in mechanism, possibly producing different depth of knockdown but similar clinical effects so far.