This biweekly Women’s Health update highlights regulatory momentum, late-stage clinical results, access setbacks, and public health partnerships across oncology and menopause care.
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In Today’s Newsletter
🧬 Roche giredestrant Phase III update [1] [Switzerland • 09 Mar 2026]
https://www.roche.com/media/releases/med-cor-2026-03-09
Context: Phase III persevERA tested giredestrant plus palbociclib in first-line ER-positive, HER2-negative locally advanced or metastatic breast cancer.
Key point: Roche said the study did not achieve statistically significant PFS improvement versus letrozole plus palbociclib, though a numerical improvement was observed.
Implication: May influence prescriber choice and payer reviews pending full data.
🎯 Enhertu wins FDA Priority Review in early breast cancer [2] [US • 09 Mar 2026]
https://www.astrazeneca.com/media-centre/press-releases/2026/enhertu-granted-priority-review-in-the-us-as-post-neoadjuvant-treatment-for-patients-with-her2-positive-early-breast-cancer.html
Context: The filing covers adults with HER2-positive breast cancer and residual invasive disease after neoadjuvant HER2-directed treatment.
Key point: AstraZeneca and Daiichi Sankyo said the FDA accepted and granted Priority Review to Enhertu (trastuzumab deruxtecan), based on Phase III DESTINY-Breast05.
Implication: May influence prescriber choice and payer reviews pending full data.
🚫 Tivdak faces draft NICE rejection in cervical cancer [3] [UK • 11 Mar 2026]
https://pharmaphorum.com/news/nice-says-no-genmab-cervical-cancer-therapy
Context: Tivdak (Genmab; tisotumab vedotin) was approved by the MHRA in December for cervical cancer after prior systemic therapy.
Key point: NICE’s initial guidance did not recommend NHS use, citing unresolved cost-effectiveness concerns and an unpublished list price.
Implication: Introduces competition that may affect pricing and formulary access.
🧪 LYMPHIR plus pembrolizumab shows Phase 1 signal [4] [US • 10 Mar 2026]
https://www.prnewswire.com/news-releases/citius-oncology-announces-positive-topline-results-from-investigatorinitiated-phase-1-study-of-lymphir-in-combination-with-pembrolizumab-in-relapsed-or-refractory-gynecologic-cancers-302709073.html
Context: University of Pittsburgh investigators ran a dose-escalation Phase 1 study in relapsed or refractory gynecologic cancers, including ovarian and endometrial malignancies.
Key point: Citius Oncology reported no unexpected safety signals and said the combination showed activity in this heavily pretreated population.
Implication: May influence prescriber choice and payer reviews pending full data.
🩺 Cadonilimab posts long-term cervical cancer survival data [5] [China • 02 Mar 2026]
https://www.akesobio.com/en/media/akeso-news/260302/
Context: Akeso presented long-term Phase II COMPASSION-03 data in recurrent or metastatic cervical cancer after prior platinum-containing chemotherapy.
Key point: The company reported durable survival outcomes with cadonilimab monotherapy, including unreached median OS in complete responders and benefit across PD-L1 subgroups.
Implication: May influence prescriber choice and payer reviews pending full data.
🤝 UNFPA and FIGO formalize women’s health partnership [6] [Global • 17 Mar 2026]
https://www.unfpa.org/press/unfpa-and-figo-sign-agreement-accelerate-innovation-and-investment-women%E2%80%99s-health
Context: The memorandum focuses on maternal and reproductive health, women’s cancers, clinician training, and digital and screening tools in low- and middle-income countries.
Key point: UNFPA and FIGO signed an MoU to accelerate innovation, investment, and health-system support for women’s health.
Implication: May expand screening, initiation, and follow-up at scale.
📘 HHS and AUA launch local estrogen education effort [7] [US • 12 Mar 2026]
https://www.hhs.gov/press-room/aua-collaboration-to-advance-womens-health.html
Context: The agreement centers on postmenopausal genitourinary syndrome of menopause and recurrent urinary tract infections.
Key point: HHS and the AUA announced an MoU to promote evidence-based clinician and patient education on local estrogen therapy.
Implication: May expand screening, initiation, and follow-up at scale.
Why It Matters
- Breast cancer remains the biggest regulatory and data driver this week, with Roche [1] posting a Phase III setback while Enhertu [2] moved closer to a new US label.
- Cervical cancer is a clear focal point, spanning access pressure for Tivdak [3], long-term monotherapy data for cadonilimab [5], and broader women’s cancer system-building via UNFPA and FIGO [6].
- Earlier-line and post-neoadjuvant treatment settings continue to attract investment, especially where recurrence risk remains high, as seen with Enhertu [2].
- Women’s health policy is broadening beyond oncology, with HHS and AUA [7] targeting under-recognized postmenopausal conditions through clinician and patient education.
- Small early-stage combination studies, such as LYMPHIR plus pembrolizumab [4], still matter because they can shape later development paths in hard-to-treat gynecologic cancers.
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FAQ
What happened in Roche’s persevERA study for giredestrant?
Roche said Phase III persevERA did not meet its primary endpoint of statistically significant PFS improvement in first-line ER-positive, HER2-negative advanced breast cancer. The company reported a numerical improvement and manageable safety, with full data to come [1].
Why is Enhertu’s Priority Review important?
The FDA’s Priority Review for Enhertu in HER2-positive early breast cancer shortens the review path for a potential post-neoadjuvant label expansion. The filing is based on DESTINY-Breast05, which AstraZeneca and Daiichi Sankyo said showed a clear invasive disease-free survival benefit versus T-DM1 [2].
Why did NICE say no to Tivdak in draft guidance?
According to the report, NICE’s preliminary decision was driven by concerns with Genmab’s economic model and cost-effectiveness, not by a new efficacy readout. Genmab said it plans to continue engaging with NICE on access [3].
What does the LYMPHIR Phase 1 result actually show?
Citius Oncology described the topline readout as a positive early safety and activity signal for LYMPHIR plus pembrolizumab in relapsed or refractory gynecologic cancers. It was an investigator-initiated dose-escalation Phase 1 study, and fuller data are still pending conference presentation [4].
How strong are Akeso’s cadonilimab data in cervical cancer?
Akeso reported long-term Phase II survival results in recurrent or metastatic cervical cancer, with particularly strong outcomes among complete responders and continued benefit across PD-L1 groups. These are company-reported follow-up data from COMPASSION-03 [5].
What are the new women’s health partnerships trying to do?
UNFPA and FIGO are targeting maternal and reproductive health innovation, workforce support, and cancer-related tools at a global level [6]. HHS and AUA are focusing more narrowly on evidence-based use of local estrogen therapy for GSM and recurrent UTIs in postmenopausal women [7].
Entities / Keywords
Giredestrant, Roche, persevERA, lidERA, evERA, pionERA, ER-positive breast cancer, HER2-negative breast cancer, palbociclib, PFS
Enhertu, trastuzumab deruxtecan, AstraZeneca, Daiichi Sankyo, DESTINY-Breast05, HER2-positive early breast cancer, post-neoadjuvant, FDA Priority Review, T-DM1
Tivdak, tisotumab vedotin, Genmab, NICE, MHRA, recurrent cervical cancer, metastatic cervical cancer, NHS access
LYMPHIR, denileukin diftitox-cxdl, Citius Oncology, pembrolizumab, KEYTRUDA, gynecologic cancers, ovarian cancer, endometrial cancer
Cadonilimab, Akeso, COMPASSION-03, recurrent or metastatic cervical cancer, PD-1, CTLA-4, PD-L1
UNFPA, FIGO, maternal health, reproductive health, cervical cancer screening, postpartum haemorrhage, digital triage
HHS, Office on Women’s Health, American Urological Association, local estrogen therapy, GSM, genitourinary syndrome of menopause, recurrent UTI
References
https://www.roche.com/media/releases/med-cor-2026-03-09
https://pharmaphorum.com/news/nice-says-no-genmab-cervical-cancer-therapy
https://www.akesobio.com/en/media/akeso-news/260302/
https://www.hhs.gov/press-room/aua-collaboration-to-advance-womens-health.html