REG - AstraZeneca PLC - US FDA decision date on camizestrant extended

AstraZenecaAnnouncement

27/05/2026 07:00

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RNS Number : 7794F  AstraZeneca PLC  27 May 2026

27 May 2026

 

US FDA decision date extended for SERENA-6 filing of camizestrant

to enable review of additional data

 

The US Food and Drug Administration (FDA) has informed AstraZeneca that it
will extend the Prescription Drug User Fee Act (PDUFA) date to review
additional data requested to support the New Drug Application (NDA) for
camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor
(palbociclib, ribociclib or abemaciclib) for the 1st-line treatment of
patients with hormone receptor (HR)-positive, HER2-negative advanced breast
cancer whose tumours have an emergent ESR1 mutation.

 

The NDA is based on positive results from the pivotal SERENA-6 Phase III trial
presented at the 2025 American Society of Clinical Oncology (ASCO) Annual
Meeting and simultaneously published in The New England Journal of Medicine
(https://www.nejm.org/) .(1) The FDA granted Breakthrough Therapy Designation
for the camizestrant combination in this setting in May 2025.

 

In April 2026, the FDA's Oncologic Drugs Advisory Committee did not reach a
majority vote in favour of the benefit of switching to camizestrant in
combination with a CDK4/6 inhibitor after detection of an ESR1 mutation in
circulating tumour DNA (ctDNA) prior to radiographic progression, based on the
SERENA-6 Phase III trial. Subsequently, the Company has provided additional
analyses requested by the FDA in support of the application, including ctDNA
clearance data linked to longer-term efficacy outcomes that will be presented
on 02 June at ASCO 2026.

 

Susan Galbraith, Executive Vice President, Oncology Haematology R&D,
AstraZeneca, said: "We are committed to continuously advancing the clinical
landscape in oncology in pursuit of improving outcomes for patients. The
SERENA-6 treatment strategy epitomises this approach by monitoring patients
for the emergence of ESR1 mutations in ctDNA and testing if a switch of
endocrine backbone therapy at this point improves outcomes. We look forward to
continuing the dialogue with the FDA in order to bring the benefits of
camizestrant with this innovative treatment strategy to eligible patients in
the US as quickly as possible."

 

On 22 May, the European Medicines Agency's Committee for Medicinal Products
for Human Use adopted a positive opinion
(https://www.astrazeneca.com/media-centre/press-releases/2026/camizestrant-recommended-for-breast-cancer-in-eu.html)
recommending approval of the camizestrant combination in this setting based on
the results of the SERENA-6 Phase III trial.

 

Camizestrant is approved in the United Arab Emirates and Saudi Arabia in this
setting. Regulatory applications are also currently under review in Japan and
several other countries based on the SERENA-6 Phase III trial.

 

Notes

 

HR-positive breast cancer

Breast cancer is the second most common cancer and one of the leading causes
of cancer-related deaths worldwide.(2 )More than two million patients were
diagnosed with breast cancer in 2022, with more than 665,000 deaths
globally.(2) In the US,( )breast cancer is the most common cancer in women,
with more than 300,000 new cases of the disease diagnosed annually, and more
than 42,000 deaths.(3) While survival rates are high for those diagnosed with
early breast cancer, only about 30% of patients diagnosed with or who progress
to metastatic disease are expected to live five years following
diagnosis.(4)

 

HR-positive breast cancer, characterised by the expression of estrogen or
progesterone receptors, or both, is the most common subtype of breast cancer
with 70% of tumours considered HR-positive and HER2-negative.(4) Estrogen
receptor (ERs) often drive the growth of HR-positive breast cancer cells.(5)

 

Globally, approximately 200,000 patients with HR-positive breast cancer are
treated with a medicine in the 1st-line setting; most frequently with
endocrine therapies that target ER-driven disease, which are often paired with
CDK4/6 inhibitors.(6-8) In the US, approximately 37,000 patients with
HR-positive metastatic breast cancer are treated with these therapies in the
1st-line setting.(6-8) However, resistance to these therapies develops in many
patients.(8) Once this occurs, treatment options are limited and survival
rates are low with approximately 36% of patients anticipated to live beyond
five years after diagnosis.(4,8)

 

Mutations in the ESR1 gene are a key driver of endocrine resistance and are
associated with poor outcomes, emerging during treatment of the disease and
becoming more prevalent as the disease progresses.(9,10) Approximately 30% of
patients with endocrine sensitive HR-positive disease develop ESR1 mutations
during 1st-line treatment before disease progression.(6)

 

The optimisation of endocrine therapy and overcoming resistance to enable
patients to continue benefiting from these treatments, as well
as identifying new therapies for those who are less likely to benefit, are
active areas of focus for breast cancer research.

 

SERENA-6

SERENA-6 is a Phase III, double-blind, randomised trial evaluating the
efficacy and safety of camizestrant in combination with a CDK4/6 inhibitor
(palbociclib, ribociclib or abemaciclib) versus treatment with an AI
(anastrozole or letrozole) in combination with a CDK4/6 inhibitor
(palbociclib, ribociclib or abemaciclib) in patients with HR-positive,
HER2-negative advanced breast cancer (patients with either locally advanced
disease, or metastatic disease) whose tumours have an emergent ESR1 mutation.

 

The global trial enrolled 315 adult patients with histologically confirmed
HR-positive, HER2-negative advanced breast cancer, undergoing treatment with
an AI in combination with a CDK4/6 inhibitor as 1st-line treatment. The
primary endpoint of the SERENA-6 trial is PFS as assessed by investigator,
with secondary endpoints including OS, and PFS2 by investigator assessment.

 

Camizestrant

Camizestrant is an investigational, potent, next-generation oral selective
estrogen receptor degrader (SERD) and complete ER antagonist that is currently
in Phase III trials for the treatment of HR-positive breast cancer.

 

AstraZeneca's broad, robust and innovative clinical development programme,
including the SERENA-6, SERENA-4, CAMBRIA-1 and CAMBRIA-2 trials, is
evaluating the safety and efficacy of camizestrant when used as a monotherapy
or in combination with CDK4/6 inhibitors to address a number of areas of unmet
need in HR-positive, HER2-negative breast cancer.

 

Camizestrant has demonstrated anti-cancer activity across a range of
preclinical models, including those with ER-activating mutations. In the
SERENA-2 Phase II trial, camizestrant demonstrated a statistically significant
and clinically meaningful improvement in PFS versus Faslodex (fulvestrant) in
the overall trial population, including in patients with ESR1 tumour mutations
irrespective of prior treatment with CDK4/6 inhibitors in patients with
ER-positive locally advanced or metastatic breast cancer, previously treated
with endocrine therapy. The SERENA-1 Phase I trial demonstrated that
camizestrant is well tolerated and has a promising anti-tumour profile when
administered alone or in combination with palbociclib, ribociclib and
abemaciclib; three widely used CDK4/6 inhibitors.

 

AstraZeneca in breast cancer

Driven by a growing understanding of breast cancer biology, AstraZeneca is
challenging, and redefining, the current clinical paradigm for how breast
cancer is classified and treated to deliver even more effective treatments to
patients in need - with the bold ambition to one day eliminate breast cancer
as a cause of death.

 

AstraZeneca has a comprehensive portfolio of approved and promising compounds
in development that leverage different mechanisms of action to address the
biologically diverse breast cancer tumour environment.

 

With Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate
(ADC), AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in
previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast
cancer, and expanding its potential in earlier lines of treatment and in new
breast cancer settings.

 

In HR-positive breast cancer, AstraZeneca continues to improve outcomes with
foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape
the HR-positive space with first-in-class AKT inhibitor, Truqap
(capivasertib), the TROP-2-directed ADC, Datroway (datopotamab deruxtecan),
and next-generation oral SERD and potential new medicine camizestrant.

 

PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has
been studied in early and metastatic breast cancer patients with an inherited
BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and
Canada) continue to research Lynparza in these settings. AstraZeneca is also
exploring the potential of saruparib, a potent and selective inhibitor of
PARP1, in combination with camizestrant in BRCA-mutated, HR-positive,
HER2-negative advanced breast cancer.

 

To bring much-needed treatment options to patients with triple-negative breast
cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with
Daiichi Sankyo to evaluate the potential of Datroway alone and in combination
with immunotherapy Imfinzi (durvalumab).

 

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide
cures for cancer in every form, following the science to understand cancer and
all its complexities to discover, develop and deliver life-changing medicines
to patients.

 

The Company's focus is on some of the most challenging cancers. It is through
persistent innovation that AstraZeneca has built one of the most diverse
portfolios and pipelines in the industry, with the potential to catalyse
changes in the practice of medicine and transform the patient experience.

 

AstraZeneca has the vision to redefine cancer care and, one day, eliminate
cancer as a cause of death.

 

AstraZeneca (https://www.astrazeneca.com/)

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development, and commercialisation of
prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are
sold in more than 125 countries and used by millions of patients worldwide.
Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow the
Company on Social Media @AstraZeneca
(https://www.linkedin.com/company/astrazeneca) .

 

Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

References

1.   Bidard FC, et al. First-Line Camizestrant for Emerging ESR1-Mutated
Advanced Breast Cancer. N Engl J Med 2025; DOI: 10.1056/NEJMoa2502929.

2.   Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of
incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J
Clin. 2024; 1- 35. DOI:10.3322/caac.21834.

3.   American Cancer Society. Key Statistics for Breast Cancer. Available
at:
https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html
(https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html)
. Accessed May 2026.

4.   National Cancer Institute. Cancer Stat facts: Female breast cancer
subtypes. Available at:
https://seer.cancer.gov/statfacts/html/breast-subtypes.html
(https://seer.cancer.gov/statfacts/html/breast-subtypes.html) . Accessed May
2026.

5.   Scabia V, et al. Estrogen receptor positive breast cancers have patient
specific hormone sensitivities and rely on progesterone receptor. Nat Commun.
2022; 10.1038/s41467-022-30898-0.

6.   Cerner CancerMPact database. Accessed May 2026.

7.   Lin M, et al. Comparative Overall Survival of CDK4/6 Inhibitors Plus
Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive,
HER2-negative metastatic breast cancer. J Cancer. 2020; 10.7150/jca.48944.

8.   Lloyd M R, et al. Mechanisms of Resistance to CDK4/6 Blockade in
Advanced Hormone Receptor-positive, HER2-negative Breast Cancer and Emerging
Therapeutic Opportunities. Clin Cancer Res. 2022; 28(5):821-30.

9.   Brett O, et al. ESR1 mutation as an emerging clinical biomarker in
metastatic hormone receptor‑positive breast cancer. Breast Cancer Res. 2021;
23:85.

10.  Zundelevich A, et al. ESR1 mutations are frequent in newly diagnosed
metastatic and loco-regional recurrence of endocrine-treated breast cancer and
carry worse prognosis. Breast Cancer Res. 2020; 22:16.

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

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