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Agilent Receives FDA Approval for Expanded Use of PD-L1 IHC 22C3 pharmDx on Dako Omnis in Esophageal Squamous Cell Carcinoma, Triple-Negative Breast Cancer, Cervical Cancer, and Gastric or Gastroesophageal Junction Adenocarcinoma

On June 2, 2026 Agilent Technologies Inc. (NYSE: A) reported that the U.S. Food and Drug Administration (FDA) has approved the expanded use of PD-L1 IHC 22C3 pharmDx, Code GE006, for use on the Dako Omnis platform to aid in identifying patients in the United States with esophageal squamous cell carcinoma (ESCC)3, triple-negative breast cancer (TNBC)4, cervical cancer5, and gastric or gastroesophageal junction (GEJ) adenocarcinoma6, who may be eligible for treatment with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.

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This approval expands access to PD-L1 testing across four additional tumor types beyond the previously approved non-small cell lung cancer (NSCLC)7 and head and neck squamous cell carcinoma (HNSCC)8. Until now, these FDA-approved PD-L1 IHC 22C3 pharmDx indications have been available on Autostainer Link 48 (ASL48) as the only platform and are now also approved for the Dako Omnis platform. This enables pathology laboratories to consolidate PD-L1 testing across more tumor types within a single automated Dako Omnis workflow, supporting increased automation and operational efficiency.

Majken Nielsen, vice president and general manager of Agilent’s Clinical Diagnostics Division, stated: "Pathology laboratories are increasingly looking to standardize testing on automated platforms that fit seamlessly into daily workflow. By expanding PD-L1 IHC 22C3 pharmDx on Dako Omnis for additional FDA-approved indications, we’re helping labs deliver PD-L1 results more conveniently and efficiently, supporting clinicians as they identify patients who may be eligible for immunotherapy."

To support expanded use of PD-L1 IHC 22C3 pharmDx on Dako Omnis, Agilent conducted a multisite external platform performance comparison study evaluating concordance of PD-L1 IHC 22C3 pharmDx results across staining platforms (Code SK006 on the ASL48 platform and Code GE006 on Dako Omnis) for the four additional indication specimens. Study results met acceptance criteria to demonstrate inter-platform concordance for these specimens when assessed at the appropriate CPS cutoffs.

PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck & Co. (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

(Press release, Agilent, JUN 2, 2026, View Source [SID1234666390])

FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the First and Only Oral SERD With Positive Phase III Results in the Curative Setting

On June 2, 2026 Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), reported that the United States (U.S.) Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under Priority Review for giredestrant, an investigational oral selective estrogen receptor degrader (SERD), as an adjuvant treatment for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage I, II and III breast cancer. The FDA is expected to make a decision on the approval by November 30, 2026.

"Giredestrant represents the first major endocrine therapy advance in early-stage ER-positive breast cancer in decades, where the chance for cure is highest," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "The FDA’s filing acceptance brings us closer to delivering a new standard-of-care with the potential to fundamentally change the treatment paradigm for people with early-stage disease."

The filing acceptance is based on the Phase III lidERA Breast Cancer study results, which showed adjuvant giredestrant significantly reduced the risk of invasive disease recurrence or death (iDFS) by 30% compared with standard-of-care endocrine therapy (SoC ET) (hazard ratio [HR]=0.70, 95% confidence interval [CI]: 0.57-0.87, p=0.0014). At three years, 92.4% of patients in the giredestrant arm were alive and free of invasive disease versus 89.6% in the SoC ET arm. The iDFS benefit was consistent across all clinically relevant subgroups. Overall survival (OS) data were immature at the time of this analysis, but a clear positive trend was observed. Follow-up for OS will continue to the next analysis. Giredestrant was well tolerated; adverse events were manageable and consistent with its known safety profile. The treatment discontinuation rate for giredestrant was 5.3% versus 8.2% with SoC ET.

Additional analyses from the giredestrant program were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Congress. This growing body of evidence continues to reinforce the clinical benefit profile of giredestrant and its potential to meaningfully improve outcomes across ER-positive early-stage and advanced breast cancer.

The U.S. FDA recently accepted the NDA for giredestrant in combination with everolimus for those with ESR1-mutated, ER-positive advanced breast cancer based on the evERA results, with a decision expected in December 2026.

Genentech’s expanding giredestrant clinical development program spans distinct treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.

Globally, 2.3 million people are diagnosed with breast cancer each year. ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and the majority are diagnosed in the early-stage. Currently, up to a third of people eventually experience recurrence on or after adjuvant endocrine therapy treatment for early-stage breast cancer. Additionally, many have to interrupt or stop treatment early due to safety or tolerability issues, thereby increasing the risk of death. These limitations underscore the need for more effective and better-tolerated options that can enhance adherence and prevent or delay disease recurrence.

About the lidERA Breast Cancer study

lidERA Breast Cancer [NCT04961996] is a Phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of adjuvant giredestrant versus standard-of-care endocrine therapy in people with medium- or high-risk stage I-III estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. Over 4,100 patients were enrolled in the study.

The primary endpoint is invasive disease-free survival (iDFS) excluding unrelated cancers in other organs (second primary non-breast cancers). Key secondary endpoints include overall survival, iDFS including second primary non-breast cancers, disease-free survival and safety.

About giredestrant

Giredestrant is an investigational, oral, potent next-generation selective estrogen receptor degrader and full antagonist.

Giredestrant is designed to block estrogen from binding to the estrogen receptor, triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.

Giredestrant has an extensive clinical development program and is being investigated in five company-sponsored Phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)
Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)
Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)
Giredestrant plus investigator’s choice of a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)
Giredestrant plus dual HER2 blockade versus dual HER2 blockade in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)
About estrogen receptor (ER)-positive breast cancer

Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year. Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and the majority are diagnosed in the early-stage. A defining feature of ER-positive breast cancer is that its tumor cells have receptors that attach to estrogen, which can contribute to tumor growth.

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity. Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy. There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.

(Press release, Genentech, JUN 2, 2026, View Source [SID1234666389])

Personalis Highlights Early Colorectal Cancer Recurrence Detection and Ultrasensitive MRD Performance Across a Broad Set of Tumor Types at ASCO 2026

On June 2, 2026 Personalis, Inc. (Nasdaq: PSNL) reported clinical data from the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting establishing the clinical importance of ultrasensitive MRD detection across six solid tumor types, led by the VICTORI colorectal cancer and TRACERx lung cancer studies.

"Our ASCO (Free ASCO Whitepaper) data continues to build on a compelling body of evidence, including recent landmark publications, that show ultrasensitive MRD detection with NeXT Personal enables early detection of patients at risk for relapse, across a broad set of solid tumor types," said Richard Chen, MD, MS, President and Chief Medical Officer of Personalis. "These data, along with our recent Medicare approvals, further our mission to provide cancer patients with the precision MRD testing they need to help guide clinical management."

Key clinical themes and data presented at the meeting included:

Exceptional Performance in Colorectal Cancer

The prospective VICTORI study (Abstract #396), led by the University of British Columbia, monitored over 100 Stage I-IV resectable CRC patients with NeXT Personal. Highlights from the interim analysis include:

100% sensitivity for cancer relapse during surveillance, ahead of imaging: NeXT Personal successfully detected 100% of all patient relapses in the cohort ahead of clinical imaging, including all distant metastases in historically difficult-to-detect regions like the lung.
82% landmark sensitivity at 4 weeks after surgery: Just four weeks after surgery, the test detected 82% of patients who later relapsed, providing clinicians with a highly reliable early signal of cancer to inform treatment pathways.
Importance of Sub-10 ppm Sensitivity in Lung Cancer

In an oral podium presentation (Abstract #8017), investigators from University College London utilized the landmark TRACERx cohort to analyze 431 Stage IA-IIIB non-small cell lung cancer (NSCLC) patients using NeXT Personal. The study demonstrated the clinical utility of detecting ctDNA at ultra-low thresholds:

Consistent Ultra-Low Limits of Detection: NeXT Personal demonstrated consistent detection of ctDNA at ultra-low levels in this study, achieving a median limit of detection (LOD) of 1.66 ppm.
Prevalence of Sub-10 ppm Detections: Building on prior NeXT Personal publications showing approximately 40% of TRACERx detections were in the ultrasensitive range (<100 ppm), this additional analysis showed that a significant portion of detections are found at the lowest limits of detection less than 10ppm. Approximately 21% of pre-operative adenocarcinoma and 18% of post-operative landmark detections were below 10 ppm—thresholds frequently missed by less sensitive assays.
Clinical importance: The clinical importance of detecting these ultra-low levels was established. Patients with post-operative landmark detections below 10 ppm (within 10–120 days post-surgery) experienced a 3-fold increased risk of recurrence compared to patients with undetectable ctDNA, potentially enabling much earlier clinical intervention.
Growing Breadth of Evidence Across Diverse Solid Tumors

Beyond colorectal and lung cancers, ASCO (Free ASCO Whitepaper) presentations highlighted the ultrasensitive performance of NeXT Personal in a broad array of additional tumor types:

Ovarian Cancer (Abstract #233): In collaboration with MD Anderson Cancer Center, 72 patients with high-grade epithelial ovarian cancer were evaluated following frontline chemotherapy and surgery. ctDNA detection correlated with a 3.5-fold risk increase for progression. Overall, NeXT Personal showed comparable sensitivity and specificity to second-look laparoscopy (SLL), suggesting its potential as a non-invasive SLL alternative.
Endometrial Cancer (Abstract #277): MD Anderson investigators found that ctDNA clearance post-treatment in 99 Stage I-IV patients reduced recurrence risk 29-fold. Notably, 46% of detections were in the ultrasensitive range, reinforcing the need for high-sensitivity testing.
Melanoma (Abstract #288): A NeXT Personal study from the University Medical Center Hamburg-Eppendorf (UKE) on 98 unresectable and resected melanoma patients demonstrated that ctDNA clearance and on-treatment dynamics predicted response. The unresectable melanoma cohort demonstrated 100% pre-treatment baseline ctDNA detection in first-line patients, with early on-therapy ctDNA decreases associated with a reduced risk of progression. The resected melanoma cohort demonstrated that increasing ctDNA during adjuvant therapy was associated with an approximately 5-fold higher risk of distant metastasis, and ultrasensitive monitoring identified recurrences a median of 212 days prior to imaging.
Renal Cell Carcinoma (Abstract #30): Investigators from the Instituto de Investigación Sanitaria (IDIS) demonstrated that ultrasensitive ctDNA detection and molecular clearance serve as robust prognostic markers in advanced renal cell carcinoma. NeXT Personal demonstrated a high pre-treatment baseline ctDNA detection rate of 84%. Patients who failed to achieve molecular ctDNA clearance (mCR) during first-line therapy experienced significantly worse outcomes, including a more than 7-fold increase in the risk of progression and a nearly 4-fold increase in the risk of death.

(Press release, Personalis, JUN 2, 2026, View Source [SID1234666388])

Cencora to Support U.S. Distribution of Kite’s CAR T-Cell Therapies

On June 2, 2026 Cencora reported an agreement with Kite, a Gilead Company, to support the distribution of Kite’s U.S. Food and Drug Administration (FDA)-approved CAR T-cell therapies, Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel).

The collaboration is designed to support efficient access to the cell therapies at the increasing number of authorized treatment centers in the U.S., including health systems and community oncology practices.

"Our focus is on ensuring every appropriate patient who needs our CAR T-cell therapies can access and benefit from these treatments," said Christophe Griolet, U.S. Vice President, General Manager, Kite. "Cencora has a proven track record of supporting complex therapies. As we expand our treatment center network, Cencora’s specialty distribution infrastructure and expertise will support a seamless experience across new and existing sites, reducing provider barriers and enabling us to meet patients where they are."

"Delivering on the promise of CAR T requires a connected ecosystem," said Mark Kelley, Senior Director, Enterprise Cell and Gene Therapy (CGT) Business Development and Account Management, Cencora. "We share Kite’s commitment to expanding patient access and will deliver the services needed to help these therapies reach the patients who need them."

"Cell therapies are individualized treatments made from a patient’s own cells, and pose unique challenges to healthcare providers, including health systems and community practices," said Melissa Lattanzi, Vice President of Emerging Therapies, Cencora. "As Kite expands its treatment center network, we will leverage our distribution infrastructure and services to support efficient access and reduce administrative burdens — including order management — across sites of care, advancing Kite’s goal to bring therapies closer to patients’ homes."

Through its CGT service line, Cencora provides developers integrated solutions across the product lifecycle to help them bring products to market, streamline market entry and support efficient access. To learn more about Cencora’s CGT capabilities, visit: View Source

(Press release, Kite Pharma, JUN 2, 2026, View Source [SID1234666387])

CAVHANZA™ (nilotinib) Orally Disintegrating Tablets: A New, FDA-approved Treatment Offering PPI and H2RA Flexibility for Ph+ CML Patients

On June 2, 2026 Cycle Pharmaceuticals (Cycle) reported the FDA approval of CAVHANZA (nilotinib) Orally Disintegrating Tablets. Launching soon, the CAVHANZA formulation is specifically designed to improve solubility and dissolution rate, enabling maintained bioavailability with concomitant use of acid-reducing agents such as proton pump inhibitors (PPIs) and/or H₂ antagonists (H₂RAs) without timing restrictions.

This will be a first in the nilotinib market, addressing a known challenge in Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) treatment, where 25% of patients are co-prescribed PPIs or H₂RAs – medications that can compromise treatment efficacy.3 In clinical trials, CAVHANZA demonstrated no food effect and can be taken without regard to meals, reducing food-related burden and supporting more flexible dosing, potentially improving treatment outcomes.1,2,4 Additionally, as an orally disintegrating tablet, CAVHANZA may support patients who have difficulty swallowing while also offering flexibility to take the treatment with or without water.1

CAVHANZA is indicated for the treatment of:

Newly diagnosed adults with Ph+ CML in chronic phase; and1
Adults with chronic and accelerated phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib.1
"We’re excited to be able to offer the CML community another TKI option that may better suit their needs," said Victoria Dickinson, Chief Product Officer at Cycle. "Finding the right treatment that fits a patient’s needs and lifestyle can be a stressful step in a patient’s treatment journey. Bringing another option to market – backed by Cycle VitaTM, our dedicated patient support* program – is an exciting prospect for Cycle."

To prepare CAVHANZA for market, Cycle partnered with Flex Pharma (Flex), who specialize in advanced formulation solutions and has developed an improved formulation of the second-generation TKI – built on years of established nilotinib efficacy.

Christian Wertz, PhD, President of Flex, added "This collaboration reflects Flex’s strategy as a technology-driven company advancing differentiated 505(b)(2) oncology therapies. Leveraging our proprietary ElectroNanoSpray (ENS) platform, we reformulate established oncology molecules to enhance bioavailability and optimize dosing performance. Together with Cycle’s rare-disease commercialization expertise, we aim to efficiently deliver improved treatment options for patients with rare leukemias."

Cycle has been delivering patient-focused treatments since 2017. The approval, and upcoming launch, of CAVHANZA represents the 10th product in Cycle’s portfolio and the 2nd product to enhance treatment options for patients living with Ph+ CML.

Learn more about CAVHANZA at View Source

Warning: QT Prolongation and Sudden Deaths

Nilotinib prolongs the QT interval. Monitor for hypokalemia or hypomagnesemia and correct deficiencies. Obtain ECGs to monitor the QTc at baseline on day 7, and periodically thereafter, and following any dose adjustments.

Sudden deaths have been reported. Avoid use in patients with hypokalemia, hypomagnesemia or long QT syndrome.

Avoid concomitant drug use with QT-prolonging drugs and strong CYP3A4 inhibitors.

Indications

CAVHANZA (nilotinib) is a kinase inhibitor indicated for the treatment of:

Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).

Adults with CP Ph+ CML or accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy.

Contraindications

CAVHANZA is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome.

Important Safety Information

Warnings and Precautions:

Substitution between nilotinib products requires dose conversion to avoid medication errors.
Monitor for myelosuppression; manage with dose adjustments or interruptions.
Cardiovascular and arterial occlusive events have been reported; assess and monitor cardiovascular risk.
Pancreatitis risk: monitor serum lipase; interrupt dosing if abdominal symptoms occur with lipase elevations.
Hepatotoxicity has been reported, with higher risk in pediatrics. Monitor liver function tests regularly.
Correct and monitor electrolyte abnormalities throughout treatment.
Tumor lysis syndrome has been reported; ensure hydration and correct uric acid before initiating treatment.
Serious hemorrhage may occur; advise patients to report signs and symptoms of bleeding.
Monitor for fluid retention and manage accordingly.
Growth retardation has been reported in pediatric patients. Monitor growth and development.
Can cause fetal harm; advise use of effective contraception during and 14 days after treatment.
Monitor BCR-ABL transcript levels in patients discontinuing treatment and manage loss of response appropriately.
Adverse Reactions:

Common non-hematologic adverse reactions include rash, pruritus, headache, nausea, fatigue, alopecia, myalgia, abdominal pain, constipation, diarrhea and vomiting. Hematologic adverse reactions include thrombocytopenia, neutropenia, and anemia. Serious adverse reactions include QT prolongation, sudden deaths, febrile neutropenia, and intracranial hemorrhage. Postmarketing reports include thrombotic microangiopathy, facial paralysis, and osteonecrosis.

Drug Interactions:

Avoid concomitant use with strong CYP3A inhibitors or inducers. Dose reduction is recommended if strong CYP3A inhibitors cannot be avoided. Avoid drugs that prolong the QT interval, including anti-arrhythmics.

Use in Specific Populations:

Pregnancy: CAVHANZA can cause fetal harm when administered to a pregnant woman.

Lactation: Breastfeeding is not recommended during treatment with CAVHANZA and for 14 days after the last dose.

Pediatric use: CAVHANZA is not approved for use in pediatric patients. Monitor growth and development if used.

Due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Geriatric use: No major differences for safety were observed in patients ≥65 years taking CAVHANZA.

For more detailed information, please refer to the full Prescribing Information at View Source

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at 1-855-831-5413, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

(Press release, Cycle Pharmaceuticals, JUN 2, 2026, View Source [SID1234666386])