FDA shared on LinkedIn about the accelerated approval of camizestrant (Etcamah), marking a groundbreaking shift toward molecular-guided therapy in advanced breast cancer management:
“FDA expands treatment options for women with advanced breast cancer!
The FDA granted accelerated approval to Etcamah (camizestrant), in combination with a CDK4/6 inhibitor, for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer who develop an ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy.
This marks the first FDA approval of a cancer therapy guided by the detection of a resistance mutation in circulating tumor DNA (ctDNA) before imaging tests show disease progression – reflecting FDA’s commitment to advancing medical innovation and getting new treatments to patients faster.”
Leading medical experts and oncologists shared their reactions and commentary on this landmark decision:
Matthew Kurian, Executive Committee Member at KYSCO:
“4 breast cancer FDA decisions to watch as we close out 2026
- Giredestrant – LidERA
Could change the standard of adjuvant endocrine therapy for the first time in decades. - Giredestrant + everolimus – evERA
A great potential option for those hesitant about simply going from one CDK4/6 inhibitor to another after progression. - Tucatinib + HP – HER2CLIMB-05
I like this for patients who prefer the classic THP induction – come off chemo – maintenance approach, versus DB-09 and essentially continuous T-DXd-based therapy. Especially interesting as we see just how durable responses can be approaching the 2-year mark. - Camizestrant – SERENA-6
Perhaps the most fascinating concept: detect ESR1 resistance in ctDNA and switch therapy before radiographic progression. Could have implications far beyond this one drug.
A lot could still change in breast oncology before 2026 is over. Great overview from CURE.”
Kamel Abou Hussein, Director of Breast Medical Oncology at MD Anderson Cancer Center at Cooper:
“So glad to see the accelerated approval (confirmatory trials required!) of camizestrant based on the results of the landmark SERENA-6 trial.
SERENA-6 represents an important step forward in how we think about endocrine resistance in HR-positive/HER2-negative advanced breast cancer; not simply waiting for radiographic progression, but using ctDNA to detect an emerging ESR1 mutation and intervene earlier.
The trial demonstrated a clinically meaningful improvement in progression-free survival with a strategy of switching to camizestrant while continuing CDK4/6 inhibition, reinforcing the potential of molecular monitoring to guide treatment before overt disease progression.
This is more than another endocrine therapy approval. It is a meaningful step toward a more dynamic, biomarker-driven approach to metastatic breast cancer care.
Congratulations to everyone who contributed to the SERENA-6 study and to the patients who made this progress possible. An exciting moment for our field!”
Erika Hamilton, Chief Development Officer, Late Phase and Director, Breast Cancer Research Program at Sarah Cannon Research Institute:
“SERENA6 just got approval by FDA!
This isn’t ‘just’ a great new drug approval in breast cancer. Camizestrant is an oral SERD that now has approval in 1L (or maybe 1.5L if you want to call it that) breast cancer. It’s incredibly well tolerated and we’ve had the opportunity to treat many patients SCRI Oncology Partners, Sarah Cannon Research Institute on it since phase I.
But why this is so important in breast cancer, is that it shepherds in the beginning of a new paradigm. The ability to use molecular testing, the emergence of ESR1m during a patients treatment, to change their treatment in the absence of progression. What is really important here is the advance of progression part and is incredibly novel in breast cancer.
It’s been a controversial road and honestly all the questions still aren’t answered. But that’s not suprising as it often happens in cancer clinical trials….the data matures as we go.
Additionally, stay tuned for more camizestrant trials including SERNA-4 which will report soon for upfront cami with CDK in the 1st line as well as CAMBRA-1 and CAMBRIA-2 which tests cami in the adjuvant setting either up front or as a switch strategy for extended endocrine therapy.”
Danny Burke, CEO of ecancer:
“How can we optimise CDK4/6 inhibitor therapy across the HR+/HER2− breast cancer treatment pathway? This new ecancer e-learning module provides an evidence-based overview of:
- The biological rationale for CDK4/6 inhibition
- Clinical evidence in early and metastatic disease
- Multigene assays and genomic biomarkers
- Patient selection and treatment sequencing
- Adverse-event monitoring and supportive care
- Practical, case-based decision-making
Designed for medical oncologists, specialist breast cancer nurses, oncology trainees and other members of the multidisciplinary team.”
Neil Vasan, Director of Breast Cancer Translational Research at NYU Langone Health:
“FDA granted accelerated approval for camizestrant today based on SERENA-6: switching therapy when an ESR1 mutation appears in ctDNA, before scans show progression. This is resistance defined, drugged, and tracked at the bedside. I served as Chair of the Oncologic Drugs Advisory Committee (ODAC) on this trial. My recent JAMA
piece discussed the vote and regulatory issues around detecting cancer before it is seen.”
François-Clément Bidard, Head of Center for Clinical Investigation CIC-2501 at Inserm:
“SERENA-6 approved by FDA. This is way more than another registration: the global approval of camizestrant will likely stay as an important milestone, when ctDNA-based adaptive medicine became a validated approach to tackle tumor resistance – for the patient benefits.
A great day for precision oncology, and the end of a long, very interesting and ocasionnaly eventful journey, from the exploratory PADA-1 designed around palbociclib 10 years ago, to S6.
And also the beginning of a whole new approach, where tumor dynamics under therapy can be monitored to proactively adapt treatment strategies before patients suffer from significant tumor regrowth and spread – which are responsible for tumor symptoms and the progressive alteration of patients’ general condition throughout the metastatic disease.
This evolution of our treatment paradigm took more than a village: thanks to the many researchers who paved the way with ESR1m discovery and characterization, all people involved in PADA-1 and S6 (patients, investigators, committee members, Unicancer staff, Pfizer and AstraZeneca teams).”
Sophie Blake, People and Culture Lead at Saragoosa:
“I can’t read the full article as it’s behind a paywall, but I knew the beautiful Fionnuala through our local support group for women living with metastatic breast cancer.
NICE refusal to fund Enhertu for women with HER2-low metastatic breast cancer has been devastating. Fionnuala is heartbreakingly one of the women who needed this life extending treatment and has now died before her time. When Enhertu first came out, my oncologist told me it would be my next line of treatment. We were so excited about this ‘wonder drug’. Then NICE decided it wasn’t ‘cost-effective’.
In 2022, NICE changed its severity modifier, effectively downgrading metastatic breast cancer despite it being incurable, with median survival of just 3–5 years from diagnosis. In doing so they removed funding towards it.
Yet MBC is the leading cause of death in women under 60. NICE has since received additional Government funding. Yet we are still being told they are negotiating with manufacturers over price. How many more years of negotiations? While NICE ‘talks’ women are dying. Scotland has approved Enhertu and so many countries around the world are moving forward. Yet women in England, Wales and Northern Ireland are being left behind. Fionnuala deserved more time.
So do thousands of women living with metastatic breast cancer. How many more women have to die before NICE decides our lives are worth the cost?”
You can also read:
FDA Grants Accelerated Approval to Camizestrant for ESR1-Mutated Advanced Breast Cancer
