Watch Our Video Summary Capturing Top Women’s Health News from the Last Two Weeks
From Enhertu’s IDFS win in early HER2+ breast cancer, FDA approval of Inluriyo for ESR1-mutated metastatic breast cancer, and HHS/FDA review of mifepristone REMS—this week’s women’s health and digital health signals are powerful. We span breast cancer, HIV prevention, ovarian cancer, digital health, and medical device interoperability, with regulatory updates and market-access advances, underscoring expanded patient access and strategic pipeline investment.
Top Stories Covered in This Video
💊 Enhertu tops T-DM1 on IDFS in DESTINY-Breast05 [1] [US • 29 Sep 2025]
Key point: Interim readout: Enhertu (fam-trastuzumab deruxtecan-nxki) improved invasive disease-free survival vs T-DM1 in HER2+ early breast cancer with residual disease post-neoadjuvant (endpoint met; OS immature).
Context: Second positive Ph3 in early setting (DESTINY-Breast05; plus DESTINY-Breast11 neoadjuvant); data slated for ESMO 2025 Presidential Symposium. Safety consistent with label.
Implication: May influence prescriber choice and payer reviews pending full data.
✅ FDA greenlights Inluriyo (imlunestrant) for ESR1-mutated MBC [2] [US • 25 Sep 2025]
Key point: Approval for adults with ER+, HER2–, ESR1-mutated advanced/metastatic breast cancer after ≥1 line of ET; EMBER-3 showed PFS benefit (5.5 vs 3.8 mo; HR 0.62).
Context: Oral ER antagonist; once-daily dosing; common AEs largely Grade 1–2; label includes embryo-fetal toxicity warning and CYP3A interactions.
Implication: May influence prescriber choice and payer reviews pending full data.
🏛️ HHS/FDA to re-evaluate mifepristone REMS [3] [US • 25 Sep 2025]
Key point: Following a letter from 22 state AGs, HHS Sec. Robert F. Kennedy Jr. and FDA Comm. Marty Makary will study safety of current REMS and consider modifications.
Context: Prior REMS changes expanded access (incl. telehealth/mail). Agency cites need to assess recent safety claims; underlying dataset not peer-reviewed.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🌍 $40/yr lenacapavir PrEP for LMICs from 2027 [4]
https://www.clintonhealthaccess.org/news/unitaid-chai-wits-rhi-dr-reddys-lenacapavir-agreement/
Key point: Unitaid/CHAI/Wits RHI deal with Dr. Reddy’s to supply generic lenacapavir for HIV prevention at ~US$40/yr in 120 LMICs starting 2027; oral loading capped at US$17.
Context: Follows Gilead voluntary licenses; complements GF/PEPFAR procurement plans. Aim is competitive multi-supplier market and rapid scale-up.
Implication: May expand screening, initiation, and follow-up at scale.
🤝 Glenmark licenses Hengrui’s HER2 ADC for emerging markets [5] [24 Sep 2025]
Key point: Glenmark to pay $18M upfront, up to $1.09B milestones for rights to trastuzumab rezetecan in select territories (ex-US/EU/JP/China, etc.).
Context: Rezetecan (exatecan-based payload) positioned vs Enhertu; approved in China for 2L NSCLC with HER2 mutations; breast cancer filing under review.
Implication: Signals pipeline investment and modality expansion.
💷 AbbVie to launch Elahere in UK at US list price [6] [UK • 30 Sep 2025]
Key point: AbbVie plans UK launch of Elahere at a list price matching US list price; subject to ongoing NICE discussions.
Context: Divergent US/EU pricing norms; company says talks will determine timing/access.
Implication: Introduces competition that may affect pricing and formulary access.
🏥 Galeon × Samsung: ultrasound→EHR integration [7] [France • 23 Sep 2025]
https://atlantis.galeon.care/en/news/galeon-formalizes-its-partnership-with-samsung
Key point: Formal partnership to natively ingest Samsung ultrasound data into Galeon EHR; Galeon to provide a free connector for each Samsung ultrasound in hospitals.
Context: Aims to reduce data silos, streamline clinician workflows, and enable device-to-record interoperability.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.
🔒 Google & Flo settle period-app privacy suit for $56M [8] [US • 25 Sep 2025]
Key point: Google to pay $48M, Flo $8M to settle claims of sharing menstrual/pregnancy data for ads (2016–2019); Meta found liable by jury, damages pending.
Context: Settlement awaits court approval; defendants deny wrongdoing; CIPA penalties alleged by plaintiffs.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
Why it matters
- Early HER2+ breast cancer may see treatment sequencing shift if Enhertu’s adjuvant benefit holds at full readout [1].
- Oral ER antagonists like imlunestrant expand options for ESR1-mutated disease and could reshape post-CDK4/6 pathways [2].
- REMS changes to mifepristone could alter telehealth access and pharmacy dispensing models nationally [3].
- A $40/yr long-acting PrEP price point could catalyze LMIC HIV prevention scale-up alongside donor procurements [4].
- ADC competition and territory deals broaden access and may pressure pricing across HER2 franchises [5][6].
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FAQ
What did Enhertu show versus T-DM1 in early breast cancer?
Enhertu improved invasive disease-free survival at interim in DESTINY-Breast05; OS not yet mature. Safety aligned with known profile [1].
How effective is Inluriyo (imlunestrant) in ESR1-mutated MBC?
In EMBER-3, Inluriyo improved PFS vs fulvestrant/exemestane (5.5 vs 3.8 months; HR 0.62) with mostly Grade 1–2 AEs; now FDA-approved for this population [2].
Is mifepristone access changing now?
Not immediately. HHS/FDA plan a review of the current REMS (including telehealth/mail). Any modifications would follow the study [3].
When will $40/yr lenacapavir be available in LMICs?
The Unitaid/CHAI/Dr. Reddy’s plan targets 2027, pending regulatory approvals; loading oral dose capped at US$17 [4].
Which markets did Glenmark license for Hengrui’s rezetecan?
Select emerging markets; excludes US, Canada, Europe, Japan, greater China, Central Asia, and some others [5].
Will Elahere actually launch in the UK at US price?
AbbVie intends to, but NICE negotiations will determine timing and access details [6].
Entities / Keywords
Enhertu (fam-trastuzumab deruxtecan-nxki); T-DM1 (trastuzumab emtansine); DESTINY-Breast05/-11; AstraZeneca; Daiichi Sankyo.
Inluriyo (imlunestrant); EMBER-3; Eli Lilly; ESR1 mutation; ER+, HER2– MBC.
Mifepristone; REMS; HHS; FDA; telehealth; mail dispensing.
Lenacapavir (PrEP); Unitaid; CHAI; Wits RHI; Dr. Reddy’s; LMIC access; $40/yr.
Trastuzumab rezetecan; Jiangsu Hengrui; Glenmark; ADC licensing.
Elahere (ovarian cancer ADC); AbbVie; NICE; UK pricing.
Galeon EHR; Samsung Healthcare France; ultrasound data integration.
Google; Flo Health; Meta Platforms; CIPA; health data privacy.
References
https://www.clintonhealthaccess.org/news/unitaid-chai-wits-rhi-dr-reddys-lenacapavir-agreement/
https://atlantis.galeon.care/en/news/galeon-formalizes-its-partnership-with-samsung