‘A Meaningful Step Forward’: A Wave of FDA Approvals Bring Fresh Hope to Breast Cancer Patients

Below are several of the newest therapies already making an impact.

Datopotamab Deruxtecan (Datroway)

Patients facing advanced triple‑negative breast cancer know how unforgiving this disease can be, especially when immunotherapy isn’t an option. Now, following the FDA’s approval of datopotamab deruxtecan (brand name Datroway), there’s a new option for a group of patients in serious need.

The approval is for patients with a type of breast cancer known as triple-negative breast cancer who are not good candidates for surgery (unresectable) or immunotherapy, a treatment that uses the body’s reengineered immune cells to fight the cancer.

“This is a huge win for our metastatic triple-negative breast cancer patients. My hope is that this will allow more options for patients and replace our traditional chemotherapies that did not work as effectively in the past,” Dr. Matt Kurian, a medical oncologist at St. Elizabeth’s Yung Family Cancer Center, tells SurvivorNet.

The approval is based on results from the TROPION‑Breast02 Phase 3 clinical trial, which showed that Datroway extended survival by about 5 months compared with standard chemotherapy.

Datroway is a type of targeted cancer treatment known as an antibody-drug conjugate. These drugs combine targeted therapy and chemotherapy.

“This is a meaningful step forward,” Dr. Premji said.

Sacituzumab Govitecan (Trodelvy), Two First-Line Triple-Negative Breast Cancer Indications

People with metastatic triple-negative breast cancer now have a new first-line treatment option with Trodelvy, either alone or combined with Keytruda, depending on their cancer.

Two phase 3 studies, ASCENT-03 and ASCENT-04/KEYNOTE-D19, have helped doctors understand whether a drug called Trodelvy should be used earlier in treatment for certain patients with advanced triple-negative breast cancer.

ASCENT-03 studied Trodelvy compared with chemotherapy in patients with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer who were not candidates for PD-1/PD-L1 immunotherapy. ASCENT-04/KEYNOTE-D19 studied Trodelvy plus pembrolizumab, an immunotherapy drug also known as Keytruda, compared with chemotherapy plus pembrolizumab in patients whose tumors expressed PD-L1.

Dr. Sara Tolaney, a breast medical oncologist at Dana-Farber Cancer Institute, told SurvivorNet that the newer data strengthen the case for using this type of treatment earlier.

“I think the data that we’re seeing really continued to confirm that Trodelvy should be a first-line standard of care option for our patients with metastatic triple-negative breast cancer,” Dr. Tolaney said.

Palbociclib (Ibrance) for HR+/HER2+ Disease

The FDA has approved targeted drug palbociclib (Ibrance) in combination with trastuzumab (Herceptin) and endocrine therapy, with or without pertuzumab (Perjeta), as a maintenance treatment for adults with a type of advanced breast cancer known as hormone receptor-positive (HR+), HER2-negative (HER2-).

Dr. Sonya Reid, an Associate Professor of Medicine in the Division of Hematology/Oncology at Vanderbilt-Ingram Cancer Center, calls the approval “practice-changing for our patients with HR+/HER2+ metastatic breast cancer.”

The new treatment combines three medicines that work together to attack the cancer from multiple directions at once:

• Palbociclib (brand name: Ibrance) is a pill that helps slow cancer growth by blocking signals that tell cancer cells to divide.
• Trastuzumab (brand name: Herceptin) targets and attacks a specific protein on cancer cells called HER2.
• Endocrine (or hormonal) therapy lowers or blocks the estrogen and progesterone hormones that fuel this type of cancer’s growth.

Some patients may also receive pertuzumab (brand name: Perjeta), a second HER2-targeting medicine that works alongside Herceptin to more fully block those cancer-driving signals.

It is intended for patients whose disease has not progressed following initial chemotherapy and HER2-directed treatment. It’s important to note that investigators leading the trial excluded patients who progressed during induction chemotherapy, which likely introduces selection bias toward patients with favorable disease biology.

Gedatolisib (Revtorpyk)

Gedatolisib (brand name: Revtorpyk) offers a new treatment option for patients with a specific type of advanced breast cancer categorized as HR‑positive (HR+), HER2‑negative (HER2-). The approval is specifically for patients who do not have PIK3CA mutations, a targetable characteristic, and expands choices for many patients who previously had few targeted options.

Gedatolisib is given alongside fulvestrant, a well-established drug that starves these cancers of the estrogen they feed on, and in some cases, a third medicine, palbociclib, is added on top.

The fact that gedatolisib is approved specifically for people whose tumors do not carry a PIK3CA mutation is important.

“Some tumors have mutations in their DNA, such as PIK3CA, for which targeted drugs have become available in recent years,” Dr. Anne O’Dea, Breast Medical Oncologist at The University of Kansas Cancer Center, tells SurvivorNet.

“PIK3CA is a part of a larger cellular signaling pathway within cancer cells that allows these cells to grow and divide. Existing drugs that inhibit PIK3CA target only a single component of the pathway, creating an opportunity for cancer cells to become resistant to that treatment and stop it from working effectively,” Dr. O’Dea adds.

“Gedatolisib is the first FDA-approved therapy that inhibits this pathway more broadly, which we believe can help overcome resistance, thus allowing the medicine to work more effectively and for a longer time.”

Camizestrant (Etcamah), Accelerated Approval

The FDA granted accelerated approval to a drug called camizestrant (Etcamah) in combination with a CDK 4/6 inhibitor for adults with HR‑positive (HR+), HER2‑negative (HER2-) advanced breast cancer who develop an ESR1 mutation while getting treatment with an aromatase inhibitor + CDK4/6 inhibitor.

The approval does not apply to everyone with this type of advanced breast cancer, though. It specifically applies to those who develop something known as an ESR1 mutation while undergoing treatment with an aromatase inhibitor (a common front-line or first treatment). These mutations help the cancer resist treatment.

“This approval gives us an opportunity to stay one step ahead of the cancer,” Dr. Jaime Alberty, Director of the Comprehensive Breast Center at NYC Health + Hospitals/Kings County, tells SurvivorNet. “For appropriate patients with advanced hormone receptor-positive breast cancer, a blood test can identify an ESR1 mutation, signaling emerging resistance to treatment, allowing us to adjust therapy before the cancer actually progresses on imaging.”

“The early switch approach of changing endocrine therapy based on the emergence of an ESR1 mutation detected through circulating tumor DNA before disease progression is seen on imaging is a new approach of using molecular changes to guide treatment decisions,” Dr. Eleonora Teplinsky, a breast and gynecologic medical oncologist at Valley Health System, tells SurvivorNet.

Imlunestrant (Inluriyo) Plus Abemaciclib (Verzenio)

The FDA approved Inluriyo (imlunestrant) together with Verzenio (abemaciclib) for a specific type of advanced breast cancer that has become resistant to older hormone treatments.

This combo works better than Inluriyo alone — keeping the cancer from growing for about 9½ months on average and giving patients another strong treatment option before needing to move on to chemotherapy.

“The combination allows us to target the estrogen receptor with a next-generation oral SERD while maintaining CDK4/6 inhibition, potentially extending the benefit of endocrine-based therapy and delaying the need for chemotherapy,” Dr. Anastasia Martynova, breast cancer specialist and medical oncologist with USC Norris Comprehensive Cancer Center, tells SurvivorNet.

Inluriyo and Verzenio have been approved for patients with breast cancer that is classified as estrogen receptor-positive (ER+) and HER2-negative (HER2-), with something called an ESR1 mutation. This means the tumor is fueled by estrogen and doesn’t overexpress the HER2 protein. An ESR1 mutation refers to a change in the estrogen receptor gene that often develops after prior hormone therapy. It can make the cancer resistant to older drugs like aromatase inhibitors.

“This FDA approval is truly a major and exciting milestone for advancing metastatic breast cancer care,” Dr. Nusayba A. Bagegni, a medical oncologist with Siteman Cancer Center at WashU Medicine, tells SurvivorNet.

Vepdegestrant (Veppanu)

The FDA approved vepdegestrant specifically for breast cancers carrying an ESR1 mutation, and also authorized the Guardant360 CDx liquid biopsy test as a companion diagnostic to identify eligible patients.

Dr. Francisco J. Esteva, Chief of Breast Medical Oncology at Lenox Hill Hospital, calls the approval a meaningful step forward.

“This introduces a biomarker‑driven, oral option for patients with ESR1‑mutated ER+ metastatic breast cancer, a setting where resistance to standard endocrine therapy is common,” he says.

ESR1 mutations, which allow cancer cells to remain active even when estrogen levels are driven down by hormonal therapy, are more common in patients previously treated with endocrine therapy, occurring in 20-40% of metastatic cases, according to the medical journal “Breast Cancer Research.”

Roughly one in three patients on long‑term aromatase inhibitors will eventually develop an ESR1 mutation, according to the report.

Trastuzumab Deruxtecan (Enhertu), Two Early-Stage Indications

The FDA granted Breakthrough Therapy Designation to trastuzumab deruxtecan (Enhertu) for a high-risk group of early breast cancer patients.

The designation, based on results from the DESTINY-Breast05 clinical trial, applies to patients with HER2-positive early breast cancer who have residual invasive disease in the breast or axillary lymph nodes following neoadjuvant therapy. Despite surgery and additional post-neoadjuvant treatment, about 20% of these patients will still develop metastatic disease.

Trastuzumab deruxtecan offers a new, potentially curative option for this population, but clinicians say careful patient selection will be essential to support shared decision-making between oncologists and patients as treatment choices grow more complex.

“It’s obviously a very potent regimen,” said Dr. Harold Burstein at Dana-Farber Cancer Institute. “DESTINY-Breast05 clinical trial showed that patients who had presented with very high-risk breast cancer did better with trastuzumab deruxtecan than the competing antibody-drug conjugate trastuzumab emtansine. It begs the question: is it better to give the drug up front or use it later for those who are really at high risk?”

What’s to Come

Many breast oncologists SurvivorNet has spoken to are looking forward to a decision on giredestrant plus everolimus for ESR1-mutated ER+/HER2− advanced breast cancer, which could come online later this year if approved by the FDA.

Helping Patients Get Answers

Cancer treatment breakthroughs are arriving fast, and for many patients and caregivers, keeping up can feel overwhelming. SurvivorNet’s AI-powered tool, My Health Questions, is built to cut through that complexity by helping people understand what new therapies mean for them and how to talk about their concerns with their care teams.

WATCH: How One Cancer Survivor and Her Sister Used “My Health Questions” to Navigate Care

Embedded throughout the SurvivorNet website, My Health Questions delivers structured, clinically grounded answers based on medical guidelines and expert-reviewed research. Users can type or speak their questions and receive responses tailored to their individual profiles, with suggested prompts available for anyone unsure where to start.

Designed to support both major treatment decisions and everyday concerns, the tool is backed by leading oncology specialists. Its purpose is to complement conversations with clinicians — helping patients arrive at appointments more informed, more prepared, and more confident.

As SurvivorNet expands its patient-focused resources, My Health Questions represents a major step forward in how technology can support people navigating cancer.

Learn more about SurvivorNet's rigorous medical review process.

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