On September 18, 2026 AstraZeneca and Daiichi Sankyo reported that Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2-targeted treatment.

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the DESTINY-Breast05 Phase III trial presented at the 2025 European Society for Medical Oncology Congress and subsequently published in The New England Journal of Medicine.1

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "This positive CHMP opinion marks a significant step towards bringing Enhertu into early-stage HER2-positive breast cancer in the EU. Enhertu cut the risk of disease recurrence by more than half compared to adjuvant standard of care for patients with residual disease, and if approved could redefine post-surgery care in the EU, keeping patients disease-free for longer and increasing the potential for cure."

John Tsai, Global Head, R&D, Daiichi Sankyo, said: "Patients with HER2-positive early breast cancer who have residual disease after neoadjuvant treatment experience a substantially higher risk of recurrence, making effective adjuvant treatment especially important. This positive CHMP opinion underscores the potential role of Enhertu in the curative-intent setting where it is critical to maximise the potential for sustained long-term outcomes."

In DESTINY-Breast05, Enhertu significantly reduced the risk of invasive disease recurrence or death (invasive disease-free survival [IDFS]) by 53% compared to trastuzumab emtansine (T-DM1) in patients with HER2-positive breast cancer with residual invasive disease following neoadjuvant therapy (based on a hazard ratio of 0.47; 95% confidence interval 0.34-0.66, p<0.0001). At three years, 92.4% of patients in the Enhertu arm were alive and free of invasive disease, compared to 83.7% of those in the T-DM1 arm.

The safety profile of Enhertu was consistent with its known profile with no new safety concerns identified.

Enhertu is approved in the US and other countries for the adjuvant treatment of patients with HER2-positive breast cancer who have residual invasive disease following neoadjuvant treatment based on DESTINY-Breast05.

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Notes

HER2-positive early breast cancer
Breast cancer is the most common cancer in women worldwide and the leading cause of cancer-related death among women.2 Approximately 2.4 million breast cancer cases were diagnosed in 2024, with more than 690,000 deaths globally.2 In Europe, approximately 540,000 cases of breast cancer are diagnosed annually, with more than 140,000 deaths.3

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including breast cancer.4 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.4 Approximately one in five cases of breast cancer is considered HER2-positive.5

Approximately one in three patients with HER2-positive early-stage breast cancer is considered high-risk, meaning they are more likely to experience disease recurrence and have a poor prognosis.6 The current standard of care in the HER2-positive adjuvant setting (after surgery) for patients with residual invasive disease in the EU is TDM-1.7

Despite receiving additional treatment with current standard of care for residual disease, some patients still experience invasive disease or death.8 Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 100% to approximately 34%.9

Adjuvant therapy represents a key opportunity to minimise the risk of recurrence and prevent progression to metastatic disease for patients with residual disease.8,10,11 New treatment options are needed in the early breast cancer setting to improve long-term outcomes for more patients.

DESTINY-Breast05
DESTINY-Breast05 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) versus T-DM1 in patients with HER2-positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.

The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS, which is defined as the time from randomisation until first invasive local, axillary or distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed DFS. Other secondary endpoints include overall survival, distant recurrence-free interval, brain metastasis-free interval and safety.

DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using the proprietary DXd ADC Technology of Daiichi Sankyo, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4mg/kg) followed by THP is approved in the US, China, India, Singapore, Brazil and Taiwan as a neoadjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or Stage III breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (5.4mg/kg) is approved in the US, Brazil, India and Canada for the adjuvant treatment for adult patients with HER2-positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial.

Enhertu (5.4mg/kg) in combination with pertuzumab is approved in more than 40 countries/regions worldwide as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial.

Enhertu (5.4mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor positive, HER2-low (IHC 1+ or IHC 2+/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, who have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

Enhertu (5.4mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

Enhertu (5.4mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval in the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu clinical development programme
A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers.

(Press release, AstraZeneca, SEP 18, 2026, View Source [SID1234670950])

On September 18, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable muscle-invasive bladder cancer (MIBC). This recommendation, which also includes KEYTRUDA SC [known as KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU), Iceland, Liechtenstein and Norway. A final decision is expected by the fourth quarter of 2026.

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"Despite advances in the treatment of muscle-invasive bladder cancer, recurrence remains a significant concern for many patients regardless of cisplatin eligibility, and up to half may be unable to receive cisplatin-based chemotherapy," said Dr. Marjorie Green, senior vice president, oncology, global clinical development, Merck Research Laboratories. "If approved, KEYTRUDA plus Padcev would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen in the European Union for people with muscle-invasive bladder cancer regardless of cisplatin eligibility, expanding on the previously approved indication."

The recommendation is based on results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304), which was conducted in collaboration with Pfizer and Astellas. In the study, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated a statistically significant improvement in event-free survival (EFS), reducing the risk of EFS events (defined as disease progression, recurrence or death) by 47% (HR=0.53 [95% CI, 0.41-0.70]; p<0.0001; 87/405 [21%] versus 146/403 [36%]) in patients with MIBC who are eligible for cisplatin-based chemotherapy compared to neoadjuvant chemotherapy (gemcitabine and cisplatin) and surgery. KEYTRUDA plus Padcev also demonstrated a statistically significant improvement in overall survival (OS), reducing the risk of death by 35% (HR=0.65 [95% CI, 0.48-0.89]; p=0.0029; 69/405 [17%] versus 99/403 [25%]) in these patients when compared to neoadjuvant chemotherapy and surgery. The trial showed KEYTRUDA plus Padcev demonstrated a statistically significant improvement in pathologic complete response (pCR) rate compared to neoadjuvant chemotherapy (55.8% [95% CI: 50.8, 60.7] versus 32.5% [95% CI: 28.0, 37.3]; p<0.0001).

In June 2026, the EC approved KEYTRUDA, which also includes KEYTRUDA SC, in combination with Padcev, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable MIBC who are ineligible for cisplatin-containing chemotherapy based on the Phase 3 KEYNOTE-905 trial.

In July 2026, KEYTRUDA in combination with Padcev was approved by the U.S. Food and Drug Administration (FDA) as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for the treatment of adult patients with MIBC based on the Phase 3 KEYNOTE-B15 trial. This also represented the first and only PD-1 inhibitor plus antibody-drug conjugate (ADC) regimen approved in the U.S. for adults with MIBC regardless of cisplatin eligibility.

About bladder cancer
Bladder cancer is the eighth most common cancer worldwide, diagnosed in more than 635,000 patients each year globally. In Europe, it is estimated there were approximately 224,700 patients diagnosed with bladder cancer and more than 70,300 deaths from the disease in 2022. According to some clinical practice guidelines, about 25% of newly diagnosed bladder cancer cases are MIBC. The standard of care for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which is shown to prolong survival. However, nearly half of patients who undergo this standard treatment experience recurrence. Additionally, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery alone.

(Press release, Merck & Co, SEP 18, 2026, View Source [SID1234670949])

On September 18, 2026 mAbxience, a majority-owned company of Fresenius SE & Co. KGaA (XETR: FRE; OTCM: FSNUY) with partial ownership from Insud Pharma; and Sandoz (SIX: SDZ / OTCQX: SDZNY), the global leader in affordable medicines, reported a licensing, development, manufacturing and commercialization agreement for an emicizumab biosimilar candidate. The collaboration agreement combines mAbxience’s proven development and manufacturing capabilities with Sandoz’s global commercial reach, creating a pathway to broaden patient access to this potential high-quality biologic medicine worldwide.

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Under the terms of the agreement, mAbxience will be responsible for the development and manufacturing of the agreed biosimilar through its state-of-the-art GMP-approved facilities in Spain and Argentina, while Sandoz will hold exclusive commercialization rights globally, excluding Argentina, Uruguay, and Paraguay. The financial terms of the agreement remain confidential. The agreement highlights the growing attractiveness of mAbxience’s development and manufacturing platform as healthcare systems prepare for a significant wave of biologic medicines losing exclusivity over the coming years.

Emicizumab is a proposed biosimilar candidate development referencing Hemlibra (emicizumab), and is indicated for the treatment of hemophilia A and represents an estimated global reference market of approximately USD 5.7 billion.

Hemophilia A is a rare genetic disorder caused by insufficient or defective factor VIII, a key blood-clotting protein. As the most common form of hemophilia, it accounts for around 80% of all cases worldwide and continues to represent a significant unmet medical need for patients and healthcare systems.

Jurgen Van Broeck, Chief Executive Officer of mAbxience, said: "This agreement with Sandoz represents a significant recognition of mAbxience’s development and manufacturing platform and the expertise of our teams. This agreement combines our capabilities with Sandoz’s global biosimilars reach and provides a clear pathway to broaden access to treatment for patients living with hemophilia A. It also reinforces our strategy of combining world-class development and manufacturing capabilities with selected commercial partnerships that can help accelerate patient access to high-quality biologic medicines worldwide."

The agreement further reinforces mAbxience’s position as a global leader in biosimilars with development and manufacturing capabilities across complex biologics. The proposed emicizumab biosimilar candidate would expand mAbxience’s presence in rare diseases and complement its growing biosimilar pipeline, which spans oncology, immunology, bone diseases, and other specialty care areas.

(Press release, mAbxience, SEP 18, 2026, View Source [SID1234670948])

On September 18, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on September 10, 2026 for FoundationOneCDx Cancer Genomic Profile to be used as a companion diagnostic for Pfizer Japan Inc’s third-generation ALK inhibitor, LORBRENA tablets 25 mg and 100 mg (generic name: lorlatinib), which is approved for ALK fusion gene-positive non-small cell lung cancer (NSCLC).

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This approval enables the detection of ALK fusion genes using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use lorlatinib for ALK fusion gene-positive NSCLC.

FoundationOne CDx Cancer Genomic Profile has continuously expanded its companion diagnostic capabilities, enabling a single comprehensive genomic profiling test to support treatment decisions for multiple medicines. With this approval, the availability of companion diagnostics for ALK fusion gene-positive NSCLC will be further expanded, which is expected to enhance patient access to appropriate treatment options.

As a leading company in oncology, Chugai is committed to realizing more advanced personalized healthcare in the oncology field and contributing to patients through the wider adoption of comprehensive genomic profiling.

Approval information The underlined and bolded part has been newly added.

Intended uses or indications

The product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib, erlotinib, gefitinib, osimertinib
EGFR exon 20 T790M alterations osimertinib
ALK fusion genes alectinib, crizotinib, ceritinib, brigatinib, lorlatinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib
BRAF V600E and V600K alterations Malignant melanoma dabrafenib, trametinib, vemurafenib, encorafenib, binimetinib
BRAF V600 alterations and BRAF fusion genes Glioma tovorafenib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab
AKT1 alterations capivasertib
PIK3CA alterations
PTEN alterations
KRAS/NRAS wild-type Colorectal cancer cetuximab, panitumumab
Microsatellite instability high nivolumab
Microsatellite instability high Solid tumors pembrolizumab
Tumor mutational burden high pembrolizumab
NTRK1/2/3 fusion genes entrectinib, larotrectinib, repotrectinib
RET fusion genes selpercatinib
ALK fusion genes alectinib
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib
FGFR2 fusion genes Biliary tract cancer pemigatinib
About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, SEP 18, 2026, View Source [SID1234670947])

On September 18, 2026 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of PADCEV (enfortumab vedotin), in combination with Keytruda (pembrolizumab), as neoadjuvant treatment (before surgery) and then continued after radical cystectomy (surgery) as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) in the European Union (EU).

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The CHMP based its positive opinion on results from the Phase 3 EV-304 clinical trial (KEYNOTE-B15), in which perioperative (neoadjuvant and adjuvant) enfortumab vedotin plus pembrolizumab significantly improved Event-Free Survival (EFS) and Overall Survival (OS) compared to standard-of-care neoadjuvant gemcitabine and cisplatin chemotherapy in adults with MIBC who were cisplatin-eligible.

Moitreyee Chatterjee-Kishore, Ph.D., MBA, Executive Vice President and Head of Oncology Development, Astellas
"Nearly half of patients with MIBC see their cancer return within five years, even after receiving neoadjuvant gemcitabine and cisplatin chemotherapy. This positive CHMP opinion brings us closer to changing that for patients across Europe, based on the significant survival improvements seen with perioperative enfortumab vedotin plus pembrolizumab."

In the trial, perioperative enfortumab vedotin plus pembrolizumab reduced the risk of tumor recurrence, progression, or death by 47% (Hazard Ratio (HR) 0.53; CI, 95%, 0.41–0.70; 1-sided p<0.0001) and reduced the risk of death by 35% (HR 0.65; 95% CI, 0.48-0.89; 1-sided p=0.0029).1

The safety profile was consistent with the known profiles of the individual medicines, and no new safety signals were observed.1 Grade ≥3 adverse events due to any cause occurred in 75.7% of patients treated with perioperative enfortumab vedotin plus pembrolizumab compared to 67.2% of patients treated with neoadjuvant chemotherapy.1

Results from the trial were recently published in The New England Journal of Medicine.1

Bladder cancer affects an estimated 200,000 people in Europe each year, with the region reporting the highest global incidence rates – particularly in Southern and Western Europe.2,3 MIBC accounts for approximately 30% of bladder cancer cases and is an advanced, aggressive form of the disease, in which cancer cells have entered the muscle wall of the bladder – increasing the risk that the disease will spread to other parts of the body if not treated effectively.4

Enfortumab vedotin plus pembrolizumab was approved by the European Commission (EC) in June 2026 as neoadjuvant and adjuvant treatment for cisplatin-ineligible adults with resectable MIBC. Approval in this setting would extend that indication to cisplatin-eligible patients, collectively covering adults with resectable MIBC regardless of cisplatin eligibility.

The EC is expected to issue a final decision on the application for enfortumab vedotin plus pembrolizumab within approximately two months. If approved, the EC’s decision will apply to all 27 European Union member states, as well as Iceland, Liechtenstein and Norway.

Astellas has already reflected the impact of the CHMP’s opinion in its financial forecast for the current fiscal year ending March 31, 2027.

About PADCEV (enfortumab vedotin)
PADCEV (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.5 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).5

Enfortumab vedotin in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is approved as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) regardless of eligibility for cisplatin-containing chemotherapy in the United States. In the European Union (EU), enfortumab vedotin in combination with pembrolizumab is approved as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adult patients with resectable MIBC who are ineligible for cisplatin-based chemotherapy.

Additionally, enfortumab vedotin plus pembrolizumab is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) regardless of cisplatin eligibility in the United States, Japan, and a number of other countries around the world. In the EU, the combination is approved for the treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.

About the EV-304/KEYNOTE-B15 Trial
The EV-304 trial is an ongoing, open-label, randomized, controlled, Phase 3 study evaluating neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab versus neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with MIBC who are eligible for cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant (before and after surgery) enfortumab vedotin in combination with pembrolizumab (arm A) or neoadjuvant chemotherapy (arm B). Curative-intent surgery (cystectomy) was performed in both arms. Enfortumab vedotin in combination with pembrolizumab was administered as a planned total of 9 cycles of enfortumab vedotin and 17 cycles of pembrolizumab, split before and after surgery.

The primary endpoint of this trial is EFS, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC or failure to undergo RC in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on BICR or death due to any cause. Key secondary endpoints include OS and pCR rate. For more information on the global EV-304 trial, go to clinicaltrials.gov.

(Press release, Astellas, SEP 18, 2026, View Source [SID1234670920])