# Inside a record quarter for new cancer treatments > Introduction: a report that never makes headlines, yet changes lives - Author: Maxime Marquette - Publisher: MadMax (https://mad-max.co) - Section: Reportage - Published: 2026-07-04 - Canonical URL: https://mad-max.co/en/article/dans-les-coulisses-dun-trimestre-record-pour-les-nouveaux-traitements-du-cancer ## Key takeaways - At least fifteen new treatments or indications were approved in the quarter, covering breast, bladder, prostate, blood and rare cancers. - Breast cancer received five approvals, including vepdegestrant, described as the first PROTAC approved by the FDA for cancer. - Bladder cancer approvals included durvalumab with BCG and atezolizumab, the first solid-tumor approval requiring circulating tumor DNA positivity. - Prostate cancer gained capivasertib for PTEN-deficient metastatic disease, and rare cancers gained zenocutuzumab and pivekimab sunirine. - The author notes persistent cost and access issues, and that accelerated approvals still need long-term confirmation. ## Introduction: a report that never makes headlines, yet changes lives ### Fifteen new **approvals** in three months On **July 2, 2026**, the **American Association for Cancer Research** published its quarterly report on **FDA** oncology **approvals** for the period from **April to June 2026**. The figure is striking: at least **fifteen new treatments** or new indications were approved in three months, covering **breast cancer**, bladder, prostate, blood cancers, and several **rare cancers**. This isn't the kind of news that dominates headlines. Yet behind every line of this technical report lies a concrete reality: **patients** who, today, have **access** to therapeutic options that simply didn't exist six months ago. ### Why this report deserves a full feature I chose to dwell on this document, often reserved for specialists, because it illustrates with rare precision the real acceleration of **Western** **oncology research**. I'll walk you through the most notable **approvals**, without ever turning the legitimate **hope** they inspire into a promise of miracles. **Breast cancer** alone received **five new approvals** this **quarter**, a figure that reflects the scale of research concentrated on this disease, which will affect, according to projections cited by the **AACR**, **nearly 322,000 women** in the United States this year. *I find it remarkable that a document as dry as an FDA quarterly report can, in reality, tell one of the finest stories of scientific progress of our time, provided you take the time to read it closely.* ## **Breast cancer**, this **quarter**'s biggest winner ### Vepdegestrant, a world first Among the most significant **approvals** is **vepdegestrant**, marketed as **Veppanu**, for **metastatic** **ER-positive, HER2-negative** **breast cancer** carrying an **ESR1** mutation. It is the **first PROTAC** ever approved by the **FDA** for cancer, an entirely new class of drugs that degrades the estrogen receptor through a mechanism different from classic hormonal **treatments**. Clinical data presented at the **SABCS 2025** conference show that patients carrying the ESR1 mutation treated with vepdegestrant experienced **significantly longer progression-free survival** than those treated with fulvestrant, the reference **treatment** until now. ### Sacituzumab govitecan, new **hope** for **triple-negative** cancer **Sacituzumab govitecan**, known by the brand name **Trodelvy**, also received an expanded approval for **metastatic** **triple-negative breast cancer**, in patients not eligible for immunotherapy targeting PD-1 or PD-L1. This drug, which targets the **TROP2** protein, is now approved as an alternative to first-line chemotherapy, and can also be combined with pembrolizumab for patients whose tumor expresses PD-L1. **Triple-negative breast cancer**, historically one of the hardest to treat due to the absence of classic molecular targets, thus gains an additional option that could change the clinical trajectory for many patients. *Watching an entirely new class of drugs emerge, PROTACs, reminds me that cancer science doesn't always progress in small steps — sometimes it makes genuine conceptual leaps.* ## **Datopotamab deruxtecan** and the expansion of ADCs ### A new targeted option for patients ineligible for immunotherapy **Datopotamab deruxtecan**, or **Datroway**, was also approved this **quarter** for **metastatic** **triple-negative** breast cancer in patients unable to receive an immune checkpoint inhibitor. Like sacituzumab govitecan, it targets the **TROP2** protein, illustrating an underlying trend toward **antibody-drug conjugates**, a rapidly expanding therapeutic class. This approval offers a direct alternative to conventional chemotherapy for a subgroup of patients who, until now, had very few targeted options, a development worth highlighting without claiming it to be a universal cure. ### Trastuzumab deruxtecan extends its reach to earlier stages **Trastuzumab deruxtecan**, already approved for HER2-positive or HER2-low **metastatic** breast cancers, received two new indications this quarter: as neoadjuvant treatment before surgery for **stage 2 or 3** cancers, and as adjuvant treatment for patients with residual disease after standard neoadjuvant treatment. This expansion into earlier stages of the disease represents a paradigm shift: a drug initially reserved for advanced forms of cancer now finds its place at the earliest lines of treatment, potentially before the disease even progresses. *This shift from a last-resort treatment to a first-line one is, to my mind, one of the most tangible signs that a drug has truly proven itself in the clinic.* ## Advances in **bladder cancer** ### Durvalumab changes the game for high-risk forms In the field of **bladder cancer**, **durvalumab**, or **Imfinzi**, was approved in combination with **BCG** for high-risk non-muscle-invasive forms of **bladder cancer**, in **patients** who have not yet received BCG treatment. Before this approval, immunotherapy was generally only accessible after BCG treatment failure. This approval therefore allows **patients** to receive immunotherapy **right from the start**, rather than waiting for prior treatment failure, which could significantly improve long-term outcomes for this **patient** population. ### Atezolizumab and a world first on circulating tumor DNA Even more notable, **atezolizumab**, marketed as **Tecentriq**, was approved as adjuvant treatment for muscle-invasive **bladder cancer** in patients with **circulating tumor DNA** after cystectomy, signaling molecular residual disease. According to the **AACR**, this is the **first FDA approval** for a solid tumor that includes a circulating tumor DNA positivity requirement. This approval marks an important methodological turning point: the decision to treat no longer relies solely on imaging or classic clinical markers, but on a precise molecular signature detected in the patient's blood. *This first approval based on circulating tumor DNA seems to me to herald an increasingly personalized oncology medicine, where every treatment decision will rest on a molecular signature unique to the patient.* ## **Prostate cancer** faces new combinations ### **Capivasertib** targets a precise molecular weakness **Prostate cancer**, which will affect roughly **one in eight men** in the United States during their lifetime according to statistics cited by the **AACR**, also gains new options. **Capivasertib**, or **Truqap**, was approved in combination with abiraterone and prednisone for metastatic prostate cancers with a **PTEN** gene deficiency. **Capivasertib** acts as an **AKT inhibitor**, a protein whose activity remains abnormally elevated in PTEN-deficient cancers, fueling tumor progression. This approval therefore directly targets a precise molecular mechanism rather than attacking the disease broadly. ### A development affecting a significant minority of patients According to the **AACR**, nearly **10% of prostate cancer cases** are diagnosed after the disease has already metastasized, a patient subgroup for whom targeted therapeutic options like **capivasertib** can make a significant difference in long-term disease management. This approval illustrates a broader trend in oncology: rather than seeking a universal treatment, research is identifying precise molecular subgroups to offer them tailored **therapeutic combinations**. *I remain fascinated by this precision medicine that, patient by patient, mutation by mutation, is redefining what it truly means to treat cancer in 2026.* ## **Rare cancers**, often overlooked by the public ### Zenocutuzumab for a rare genetic mutation **Zenocutuzumab**, or **Bizengri**, was approved for advanced **cholangiocarcinoma** carrying an **NRG1** gene fusion, an extremely rare subtype of bile duct cancer. This bispecific antibody simultaneously targets the **HER2** and **HER3** proteins, blocking the formation of a molecular complex that fuels tumor growth. For patients carrying this rare genetic fusion, this approval offers a second line of treatment where options were previously extremely limited, illustrating the importance of research on cancer subtypes that statistically affect very few patients, but whose lives matter just as much. ### Pivekimab sunirine against a rare, aggressive leukemia **Pivekimab sunirine**, or **Decnupaz**, was approved to treat **blastic plasmacytoid dendritic cell neoplasm**, a rare and aggressive form of **blood cancer**. This antibody-drug conjugate targets the **CD123** protein, universally expressed by this disease's cells, to deliver an agent capable of directly damaging cellular DNA. These approvals for **rare cancers** never generate as much media attention as treatments for the most common cancers, but they often represent the only glimmer of **hope** for patients whose disease is too rare to attract massive pharmaceutical investment. *I want to name these **rare cancers** explicitly, because they are too often invisible in general media coverage. Every patient behind these complicated names deserves to be seen, not just counted statistically.* ## **Innovations** in **cell therapy** and **hematology** ### Afamitresgene autoleucel, a first traditional approval **Afamitresgene autoleucel**, marketed as **Tecelra**, moved from an accelerated approval obtained in 2024 to **full traditional approval** this quarter, with an expanded indication now including pediatric patients aged **12 and older** with metastatic synovial sarcoma. It is the first T-cell receptor-engineered T-cell therapy ever approved, and the first **cell therapy** immunotherapy for synovial sarcoma. This conversion from accelerated to traditional approval is significant in itself: it means longer-term follow-up data confirmed the clinical benefit initially observed, an important milestone in the regulatory journey of any new treatment. ### Sonrotoclax, a new generation of BCL-2 inhibitors **Sonrotoclax**, or **Beqalzi**, received accelerated approval for **mantle cell lymphoma** refractory or relapsed after at least two prior lines of treatment including a BTK inhibitor. It is a **second-generation BCL-2 inhibitor**, designed to overcome the limitations of venetoclax, the first-generation reference treatment in this class. For patients whose lymphoma has resisted several prior lines of treatment, this new generation of inhibitors represents an additional option at a point when therapeutic alternatives are becoming increasingly scarce. *Watching a **cell therapy** move from experimental status to standard pediatric treatment within two years reminds me how fast this branch of medicine is currently evolving.* ## A quiet revolution for older patients ### Decitabine-cedazuridine, a treatment taken at home For **acute myeloid leukemia** in patients aged **75 and older** or ineligible for intensive induction chemotherapy, the combination of **decitabine and cedazuridine**, marketed as **Inqovi**, was approved in combination with venetoclax. These oral tablets allow patients to receive their treatment at home, rather than making repeated trips for infusions. This seemingly logistical detail carries considerable human weight for older patients who are often frail, for whom every trip to an infusion center represents significant physical and logistical effort. ### A new approach for stem cell transplants An allogeneic immune therapy based on **regulatory T cells**, marketed as **Tregzi**, was approved for patients with hematologic cancers undergoing a **stem cell transplant**. It is the first approved immunotherapy to use regulatory T cells, designed to help cells recover after transplant conditioning and reduce the risk of chronic graft-versus-host disease. This approval, less publicized than others, could nonetheless significantly reduce one of the most feared complications of stem cell transplants, an advance whose clinical impact deserves close monitoring in the years ahead. *Simply allowing an older patient to be treated at home rather than in a hospital is, to my mind, an advance as important as any complex new molecule.* ## What this pace of approvals reveals about **Western** research ### An acceleration owing nothing to chance This pace of **fifteen approvals in a single quarter** is no accident. It reflects decades of sustained investment in basic and clinical oncology research, largely concentrated in major North American and European research centers, as well as close cooperation between pharmaceutical companies and academic institutions. This acceleration also illustrates the growing efficiency of **FDA** regulatory processes, which have developed accelerated approval pathways that make promising treatments for serious or rare diseases available to patients more quickly, while maintaining rigorous follow-up requirements. ### A model inspiring other regions of the world This American regulatory model, combining scientific rigor with speed of execution, is increasingly inspiring regulatory agencies elsewhere in the Western world, which are seeking to shorten **access** times to innovative treatments without compromising patient safety. This positive dynamic contrasts with the difficulties in **accessing** innovative treatments still observed in several regions of the world less well equipped with research infrastructure and robust regulatory capacity. *I believe this pace of Western **innovation**, often criticized for its cost, remains one of the best arguments in favor of a research system that, despite its imperfections, continues to produce concrete results for patients.* ## The limits worth keeping in mind ### **Access** and cost, persistent challenges It would be dishonest to celebrate this report without mentioning the access and cost issues that often accompany these new treatments. The targeted therapies, antibody-drug conjugates, and cell therapies mentioned in this report generally rank among the most expensive oncology treatments, raising legitimate questions about equity of access among patients depending on their insurance coverage or country of residence. These economic issues aren't addressed in detail in the AACR report, but they inevitably accompany every new approval, and deserve to be kept in mind by any reader following this kind of news with unqualified enthusiasm. ### The time needed to measure long-term benefits Several of these approvals, notably those obtained under **accelerated approval** status, remain subject to long-term follow-up requirements before their full clinical benefit is completely confirmed. This ongoing validation process, though less spectacular than an initial approval announcement, remains essential to guarantee the real safety and effectiveness of these treatments over the long term. I therefore choose to present this report with the enthusiasm it deserves, while reminding readers that medicine advances through successive validations, rarely through immediate and definitive certainties. *The **hope** I want to convey here is real, but measured: every new approval is a step, never a definitive finish line for patients living with a cancer **diagnosis**.* ## The role of patients in this scientific acceleration ### **Clinical trials** that depend on voluntary participation Each of these **fifteen** approvals rests on the participation of thousands of volunteer patients in **clinical trials**, often over several years, before the data is judged solid enough to justify regulatory approval. This contribution, rarely highlighted in media coverage of these announcements, deserves explicit recognition. Without this participation, none of the data presented at conferences like **SABCS 2025** or the **AACR-NCI-EORTC** conference on molecular targets would exist, and this quarterly report would remain empty of any concrete content. ### A reminder for patients currently in treatment For patients currently undergoing cancer treatment, this report should serve as a reminder that open dialogue with their oncology team remains essential to assess whether one of these new approvals might apply to their specific clinical situation, based on their tumor subtype and molecular profile. No popular science article, however thorough, replaces an individualized medical evaluation, a principle I deliberately repeat in every one of my texts about medical advances. *I constantly think of the thousands of anonymous patients whose participation in **clinical trials** makes each of these approvals possible. This report belongs to them as much as to the researchers who wrote it.* ## What this means for the future of **oncology research** ### Toward ever more personalized medicine The trend that clearly emerges from this quarterly report is one of increasingly personalized oncology medicine, structured around precise molecular signatures like **ESR1** mutations, **PTEN** deficiencies, or **NRG1** gene fusions, rather than broad, generic cancer categories. This approach, though more complex to implement diagnostically, allows more precise targeting of patients likely to genuinely benefit from a given treatment, potentially reducing unnecessary side effects in patients for whom the treatment would not be effective. ### The next frontier: integrating blood biomarkers The approval of atezolizumab based on the detection of **circulating tumor DNA** may be just the beginning of a broader trend toward the systematic integration of blood biomarkers into oncology treatment decisions, an evolution that could transform how clinicians monitor recurrence and adjust treatments in real time. This technological frontier, still in its early stages, could redefine in the coming years how the entire Western health system approaches post-treatment monitoring of cancer patients. *If this trend toward blood biomarkers is confirmed, I think we will remember this quarter as a turning point, even though it didn't make headlines at the time.* ## A reminder about overall cancer statistics ### Figures that put these advances in context The AACR report notes that breast cancer will show a **five-year relative survival rate above 90%** in recent years, a figure that, while encouraging, should never obscure the difficult reality faced by patients whose disease doesn't respond to standard treatments, particularly those with triple-negative or metastatic forms. These encouraging statistics, combined with this quarter's **fifteen** new approvals, paint an overall positive trajectory for breast cancer research, without erasing the challenges that persist for the hardest-to-treat patient subgroups. ### **Prostate cancer**, a screening challenge as much as a treatment one For **prostate cancer**, the fact that nearly **10% of cases** are diagnosed after metastasis highlights a challenge that goes beyond treatment alone: **early screening**, which remains uneven across populations and health systems, even in the most medically advanced Western countries. New **therapeutic combinations** like **capivasertib** offer real hope for late-diagnosed patients, but they do not replace the crucial importance of **early** and regular **screening** for the entire at-risk male population. *I refuse to let good therapeutic news mask the persistent gaps in **early screening**. Both battles, treatment and prevention, must advance together.* ## Research funding, the blind spot of public debate ### Federal **budgets** that make this pace possible Behind every **FDA** approval lies funding that's often invisible to the public: grants from the **National Institutes of Health**, private investment from major pharmaceutical companies, and academic partnerships that together move a molecule from the lab to the patient in just a few years, a timeline that would have seemed unthinkable a generation ago. This funding, often debated during budget discussions in Washington, remains one of the least visible pillars of **Western** scientific competitiveness, an investment whose returns are measured in lives saved far more than in accounting entries. ### **International competition** that drives progress forward The speed of this quarter is also explained by increasingly fierce **international competition** among American, European, and Asian laboratories, each seeking to patent the next molecule capable of transforming the prognosis of a previously hard-to-treat cancer. This race, far from being purely commercial, directly benefits Western patients, who generally enjoy faster access to innovative treatments than in most other regions of the world, a structural advantage that would be risky to take for granted. *We too often forget that these therapeutic successes rest on research **budgets** voted far from the spotlight. Defending this funding means defending the very capacity to keep saving lives.* ## Conclusion: a quarter worth remembering ### The overall record of this exceptional period Between April and June 2026, **Western** **oncology research** produced at least **fifteen concrete therapeutic advances**, covering breast, bladder, and prostate cancer, several blood cancers, and rare cancers like NRG1-fusion cholangiocarcinoma. This pace of **innovation**, documented in black and white by the AACR, illustrates the continued vitality of Western **biomedical research**. Every approval mentioned in this text rests on years of basic research, rigorous **clinical trials**, and the participation of thousands of volunteer patients, a collective effort that deserves recognition beyond the technical, sometimes unpronounceable drug names alone. ### A measured hope to conclude I close this report with the same caution that has guided my entire argument: these advances are real, documented, and significant, but they do not constitute a definitive victory against cancer. They represent important steps in a fight that will continue to demand research, investment, and patient participation for many years to come. For patients and their families living with a cancer **diagnosis** today, this quarterly report should be read as a message of measured hope: science is advancing, concretely, quarter after quarter, even when no one is talking about it on television. *I choose to end on this note of measured hope, never promising more than what science can genuinely affirm today.* **By Maxime Marquette, columnist** ## Columnist's transparency note ### Editorial stance I am not a journalist but a **columnist and analyst**. My expertise lies in observing and analysing the geopolitical, economic and strategic dynamics that shape our world. My work is to take political strategies apart, to understand global economic movements, to put the decisions of international actors in context and to offer analytical perspectives on the changes that are redefining our societies. I do not claim the cold objectivity of traditional journalism, which stops at reporting facts. **I claim analytical clarity**, rigorous interpretation and a deep understanding of the complex issues that concern us all. My role is to give meaning to the facts, to place them in their historical and strategic context, and to offer a critical reading of events. ### Method and sources This text keeps the basic distinction between **verified facts and interpretive analysis**. The rule never changes: a factual claim is published only when a verifiable source supports it, and the sources this article actually used are listed under **Sources**, never here. **Primary source families** used by the publication, when the story has them: official statements from governments and international institutions, public statements by political leaders, reports from intergovernmental organisations, dispatches from recognised international news agencies. **Secondary source families**: specialised publications, internationally recognised news media, analyses from established research institutions, reports from industry organisations. When an article cites statistical, economic or geopolitical data, it comes from the institutions that produce it (intergovernmental organisations, central banks, national statistics offices), and the exact institution is named under **Sources**. ### Nature of the analysis The analyses, interpretations and perspectives in the analytical sections of this article are a **critical, contextual synthesis** based on the information available, the trends observed and the expert comments cited in the sources consulted. My role is to interpret these facts, to set them in the context of today's geopolitical and economic dynamics, and to give them a coherent meaning within the larger story of the changes shaping our time. These analyses reflect expertise built through continuous observation of international affairs and an understanding of the strategic mechanisms that drive global actors. This article describes a documented state of affairs on its publication date, not a prediction: later developments may shift its outlook. No update is promised in advance; when an article is corrected or completed, the change is dated in the text. ## Sources ### Primary sources - [American Association for Cancer Research — Report on FDA oncology approvals, April-June 2026 — July 2, 2026](https://www.aacr.org/blog/2026/07/02/fda-approvals-in-oncology-april-june-2026/) - [FDA — Approval of sacituzumab govitecan as monotherapy and in combination with pembrolizumab](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line) ### Secondary sources - [Gilead — FDA approves Trodelvy for first-line treatment of metastatic triple-negative breast cancer](https://www.gilead.com/news/news-details/2026/u-s--fda-approves-trodelvy-for-first-line-treatment-of-metastatic-triple-negative-breast-cancer) - [The Cancer Letter — Analysis of therapeutic targets and oncology drugs — July 2, 2026](https://cancerletter.com/drugs-and-targets/20260702_8b/) - [Yahoo Finance — The Tigerlily Foundation celebrates an FDA approval](https://finance.yahoo.com/healthcare/articles/tigerlily-foundation-celebrates-fda-approval-181500299.html) - [STAT News — Specialized health and oncology coverage](https://www.statnews.com) --- Source: Maxime Marquette, MadMax. When citing, name the author and link https://mad-max.co/en/article/dans-les-coulisses-dun-trimestre-record-pour-les-nouveaux-traitements-du-cancer