On June 23, 2026 NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) ("NeOnc" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, reported that the Department of Health – Abu Dhabi (DOH) has granted Investigational New Drug (IND) status for NEO100, the Company’s lead candidate, an intranasally administered formulation of purified perillyl alcohol designed for non-invasive nose-to-brain delivery. The authorization covers the Company’s NEO100-01, NEO100-02, and NEO100-03 protocols across Phase 1, Phase 1b, and Phase 2 studies in adults, together with pediatric studies authorized for Phase 1 and Phase 1b pending further protocol review. The authorized indication is progressive or recurrent Grade III or IV gliomas.

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The breadth of the UAE authorization, spanning three protocols and adult studies from Phase 1 through Phase 2 alongside a defined pediatric pathway, is intended to allow NeOnc to advance multiple stages of clinical development in parallel. The authorization follows the DOH’s recent IND clearance for the Company’s NEO212 program, announced in June 2026, and extends NeOnc’s clinical development footprint in the UAE across both of its lead platforms, the intranasal delivery platform represented by NEO100 and the drug-conjugation platform represented by NEO212.

In the United States, NEO100 has received FDA Orphan Drug, Fast Track, and Rare Pediatric Disease designations, and its lead clinical study, the NEO100-01 Phase 2a trial in recurrent IDH1-mutant high-grade glioma, is fully enrolled.

The Company expects to report top-line data from the fully enrolled NEO100-01 Phase 2a trial by the end of July 2026, representing what NeOnc believes may be one of the most important clinical milestones in the Company’s history. Based on the strength of the data observed to date and ongoing interactions with regulators, NeOnc believes the upcoming results may support one or more important regulatory pathways, including potential Breakthrough Therapy designation, expansion of existing Fast Track benefits, and enhanced development opportunities under the program’s existing Orphan Drug designation. While no assurance can be given regarding regulatory outcomes, the Company believes the upcoming data represent a significant milestone in the continued development of NEO100.

"This authorization is significant because it comes at a pivotal moment for NeOnc and the NEO100 program," said Amir Heshmatpour, Chief Executive Officer, Executive Chairman and President of NeOnc. "NEO100 has already received FDA Orphan Drug, Fast Track, and Rare Pediatric Disease designations, and we are now approaching what we believe could be one of the most important clinical milestones in our Company’s history. We anticipate reporting top-line Phase 2a data by the end of July and believe those results may position NEO100 for additional regulatory opportunities, including potential Breakthrough Therapy designation. If the data continue to reflect the encouraging trends observed to date, we believe NEO100 has the potential to meaningfully alter the treatment paradigm for patients suffering from recurrent high-grade gliomas. While regulatory decisions are ultimately made by the FDA, we are encouraged by the progress of the program and remain focused on bringing a non-invasive treatment option to patients facing devastating brain cancers. Our objective is not simply to advance another oncology drug candidate, but to establish a new paradigm for non-invasive delivery of therapeutics to the brain, potentially changing how CNS diseases are treated worldwide."

"NEO100 uses intranasal delivery to reach the brain directly, a practical route that circumvents the blood-brain barrier without surgery or systemic chemotherapy," said Thomas Chen, MD, Ph.D., Founder, Chief Medical Officer and Chief Scientific Officer of NeOnc. "Because it is non-invasive, this approach can enable studies in difficult groups, including children with high-grade gliomas that have few options today. An authorization spanning Phase 1 through Phase 2 with a pediatric pathway lets us pursue that work where it is needed most."

The upcoming Phase 2a readout represents the first controlled evaluation of NEO100 in recurrent IDH1-mutant high-grade glioma following encouraging earlier clinical observations. If the study meets its objectives, NeOnc believes the data could support discussions with regulators regarding accelerated development pathways and potentially serve as the foundation for future registrational planning.

High-grade gliomas, including WHO Grade III and IV disease, are among the most aggressive brain cancers, with limited treatment options after recurrence. The Company expects to work with healthcare institutions, investigators, and regulatory authorities in the UAE as clinical development activities advance.

The UAE authorization further positions NeOnc to rapidly expand clinical development activities internationally as the Company prepares for multiple anticipated regulatory and clinical milestones throughout the second half of 2026.

(Press release, Neonc, JUN 23, 2026, View Source [SID1234668924])

On June 23, 2026 Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, reported expanded availability of Precise MRD, broadening availability to patients undergoing treatment and surveillance for breast, colorectal and renal cancers. More than 6 million individuals are living with these cancers in the U.S., representing a significant expansion in access to Myriad’s ultrasensitive Precise MRD test1.

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Precise MRD is a next-generation, ultrasensitive, whole-genome sequencing-based assay that generates a personalized panel for each patient by tracking up to 1,000 variants. The test provides clinicians with a dynamic and quantitative molecular view of their patient’s disease status across the cancer care continuum, from neoadjuvant therapy through post-surgical assessment and long-term surveillance. Its ultrasensitive design enables robust detection of circulating tumor DNA (ctDNA) even in low-shedding tumors, delivering consistent performance across a range of disease settings2.

"Expanding Precise MRD into breast, colorectal and renal cancers marks a significant step forward in our broader precision oncology strategy," said Brian Donnelly, Chief Commercial Officer, Myriad Genetics. "In a single, easy-to-read report, Precise MRD delivers ultrasensitive ctDNA detection and longitudinal insights, along with the clinical interpretation support clinicians need to help guide treatment and surveillance decisions. As we continue to expand across tumor types and build clinical evidence, we believe Precise MRD will play an increasingly central role in managing cancer care."

MONITOR-Breast publication adds to growing evidence for Precise MRD
Myriad Genetics also announces the publication of results from the prospective, multi-center MONITOR-Breast study in Future Oncology, further supporting the clinical validity of Precise MRD in breast cancer. The study demonstrates that ultrasensitive ctDNA monitoring during neoadjuvant therapy provided real-time insight into treatment response and helped identify patients at increased risk for residual disease.

"MONITOR-Breast highlights the strength of a whole-genome, tumor-informed approach to MRD detection," said Dale Muzzey, Chief Scientific Officer, Myriad Genetics. "Precise MRD enables ultrasensitive ctDNA detection and longitudinal disease monitoring that captures dynamic treatment response. The ability to identify additional at-risk patients through frequent sampling, beyond a single timepoint assessment, demonstrates the importance of molecular monitoring in improving risk stratification and guiding clinical decision-making."

The study evaluated 154 patients with Stage I–III breast cancer across all molecular subtypes, analyzing 949 plasma samples collected longitudinally throughout treatment using Precise MRD to assess ctDNA status. Key findings include:

High baseline detection rates: ctDNA was detected in 93% of patients at baseline, including 20% at ultrasensitive levels below 100 parts per million (PPM).
Strong prediction of treatment response: Precise MRD predicted pathological complete response (pCR) with 100% specificity.
Post-treatment prognostic value: Patients who were ctDNA positive at the end of neoadjuvant therapy (NAT) were 47 times more likely to remain ctDNA positive after surgery.
Distinct response patterns through longitudinal testing:
78% of patients demonstrated sustained ctDNA clearance and were significantly more likely to achieve pCR.
22% showed persistent or intermittent positivity, identifying a population at elevated risk of worse outcomes. Longitudinal testing identified 44% more patients who were at risk for residual disease than testing at the post-NAT timepoint alone.
These findings add to the growing body of evidence supporting serial ctDNA monitoring throughout treatment to help clinicians personalize care decisions.

Supporting care across the cancer continuum
Precise MRD is designed for use across key points in patient cancer care, including neoadjuvant monitoring, post-surgical assessment and surveillance. It integrates into existing oncology workflows across academic and community settings and interested healthcare providers can learn more here.

About Precise MRD
The Precise MRD Test is an ultrasensitive assay that quantifies tumor levels as the patient traverses the care continuum. Built on whole-genome sequencing of tumor tissue, the test creates a unique panel of up to 1,000 patient-specific variants to measure ctDNA at ultrasensitive levels, while minimizing false positives. Precise MRD results can identify residual disease to provide prognostic information that can be used for risk stratification, track response to therapy and monitor for early signs of disease recurrence. Learn more at myriad.com/oncology/precise-mrd-test/.

(Press release, Myriad Genetics, JUN 23, 2026, View Source [SID1234668923])

On June 23, 2026 Coherus Oncology, Inc. (Nasdaq: CHRS) and Zumutor Biologics Inc. ("Zumutor"), an immuno-oncology biotech company, reported a clinical collaboration and supply agreement to conduct a Phase 1 trial of ZM008, a novel NK checkpoint anti-LLT1 monoclonal antibody in combination with LOQTORZI (toripalimab-tpzi), a next-generation PD-1 inhibitor (Trial ID: NCT06451497). The study will enroll patients with colorectal, head and neck, non-small cell lung cancer, clear cell renal cell carcinoma and urothelial cancers, among other solid tumors.

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"We are excited to partner with Zumutor Biologics on the development of LOQTORZI with ZM0008 as a novel combination treatment for cancer patients in this Phase 1 study," said Theresa LaVallee, Ph.D., Chief Scientific and Development Officer at Coherus Oncology. "This collaboration is another example of our strategy to expand potential LOQTORZI indications beyond NPC and strengthen the clinical data package in the US through cost-efficient drug supply agreements, evaluating LOQTORZI with novel mechanisms in prioritized tumor types such as NSCLC, HNSCC, and others."

ZM008, discovered using Zumutor’s proprietary fully human monoclonal antibody library INABLR, has demonstrated a favorable safety profile, with no dose-limiting toxicities or anti-drug antibodies. In an ongoing monotherapy study, ZM008 has shown clinical benefit in metastatic patients previously treated with immune checkpoint inhibitors. Targeting complementary adaptive and innate immune pathways can unlock meaningful clinical benefit, particularly in hard-to-treat "cold tumors" that remain less responsive to current immunotherapies. "This Phase 1 study will evaluate ZM008 in combination with LOQTORZI and will generate key insights into response mechanisms, identify predictive biomarkers, and refine patient selection strategies to accelerate personalized therapies," said Maloy Ghosh, Ph.D., Chief Scientific Officer of Zumutor. The trial will evaluate safety, tolerability, and the recommended dose of ZM008, enrolling up to 45 patients across dose-escalation and expansion cohorts in the United States.

"The initiation of combination studies of ZM008 with toripalimab, from Coherus Oncology, represents a pivotal milestone for our lead program," said Kavitha Iyer Rodrigues, CEO of Zumutor Biologics Inc. "Building on encouraging early clinical data, this advancement strengthens our conviction in ZM008’s potential to deliver a differentiated and meaningful immunotherapy option for patients with difficult-to-treat cancers and underscores our commitment to accelerating its clinical development."

Under the terms of the clinical trial collaboration and supply agreement, Coherus Oncology will provide LOQTORZI to Zumutor, which will be the sponsor of the Phase 1 clinical combination trial. Zumutor and Coherus each retain all commercial rights to their respective compounds, as monotherapies or combination therapies.

(Press release, Coherus Oncology, JUN 23, 2026, View Source [SID1234668922])

On June 23, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology for Bladder Cancer to include tumor-informed multiplex PCR circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) testing in the treatment algorithm for patients with MIBC.

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The updated guidelines state that the Panel "recommends the consideration of ctDNA-MRD testing as a tool for risk stratification and to determine the use of adjuvant immunotherapy after cystectomy in patients who have not received previous immune checkpoint inhibitor treatment using an FDA-approved, personalized, tumor-informed, multiplex PCR-NGS assay for ctDNA."

For the first time, NCCN Guidelines recognize that personalized, tumor-informed ctDNA-MRD has emerged as a prognostic and predictive biomarker in MIBC – a significant step forward from previous guidance.

Signatera is based on personalized, tumor-informed, mPCR-NGS technology. This technology is patented and proprietary to Natera, and cited in numerous publications. In addition, Signatera was the MRD test used in the landmark IMvigor011 trial, which generated the Phase 3 evidence needed to move the field to this much stronger recommendation. That evidence is now reflected in a Category 1 recommendation for Signatera-guided adjuvant atezolizumab, initiated at MRD-positivity within 1 year post-cystectomy. Category 1 recommendations are NCCN’s highest designation.

"This guideline update marks an important turning point for patients with muscle-invasive bladder cancer," said Matthew D. Galsky, M.D., deputy director of the Mount Sinai Tisch Cancer Center, director of Genitourinary Medical Oncology, and co-director of the Center of Excellence for Bladder Cancer at the Mount Sinai Tisch Cancer Center. "For the first time, NCCN has incorporated ctDNA-MRD testing into clinical decision-making following cystectomy. These recommendations are supported by prospective phase 3 evidence showing that a ctDNA-guided approach, using Signatera, can help guide post-surgical treatment decisions."

"These recommendations reflect years of work to generate the clinical evidence establishing MRD as a clinically actionable and predictive tool," said Kevin Masukawa, Ph.D., vice president, life cycle management, oncology at Natera. "The IMvigor011 study is an important example of how Signatera-generated evidence can help change clinical practice, and we believe this guideline update is just the beginning of a broader shift toward MRD-guided cancer care."

In May 2026, the U.S. Food and Drug Administration approved Signatera CDx as a companion diagnostic to identify patients with MIBC who are ctDNA-MRD positive and may benefit from treatment with adjuvant immunotherapy.

(Press release, Natera, JUN 23, 2026, View Source [SID1234668921])

On June 23, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the European Commission (EC) has granted marketing authorization for Trodelvy (sacituzumab govitecan-hziy) as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy. Trodelvy is the first antibody-drug conjugate (ADC) to be approved in first-line metastatic TNBC in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein.

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"This approval brings a profound sense of hope to a community that has long been waiting for progress," said Dr. Javier Cortes, Head of the International Breast Cancer Center, Madrid and Barcelona, Spain. "For women diagnosed with metastatic TNBC, particularly those who are younger, every second counts, and having an effective treatment option that can delay the progression of their disease is invaluable. This is the kind of meaningful advance our community needs."

For many living with metastatic TNBC, the most aggressive form of breast cancer, first-line therapy may be their only line of treatment, creating an urgent need for effective treatment options to be used as early as possible.

"This approval represents a significant step forward in how we treat people with first-line metastatic TNBC in Europe," said Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology at Gilead Sciences. "We have long recognized the challenges that patients and clinicians face with this aggressive cancer, and we believe this approval will provide a much-needed new option for people with metastatic TNBC."

The EC’s marketing authorization is based on data from the Phase 3 ASCENT-03 study which demonstrated a highly statistically significant and clinically meaningful progression-free survival for Trodelvy compared to standard of care chemotherapy as a first-line treatment. In ASCENT-03, Trodelvy demonstrated a 38% reduced risk of disease progression or death in patients who are not candidates for PD-1/PD-L1 inhibitors. The ASCENT-03 study utilized a patient-centered crossover design, which allowed patients in the chemotherapy arm to receive Trodelvy after their disease progressed. The EC’s approval, based on the strength of the PFS data, confirms the study’s objective to demonstrate using Trodelvy earlier provides a clinical benefit over chemotherapy for metastatic TNBC patients.

Continued Global Regulatory Filings for Trodelvy in First-Line Metastatic TNBC

Gilead has submitted a supplemental filing to the European Medicines Agency for Trodelvy in combination with Keytruda (pembrolizumab) for patients with PD-L1 positive unresectable locally advanced or metastatic TNBC, based on data from the Phase 3 ASCENT-04 study. This application is currently under review. If approved, Trodelvy has the potential to be a backbone treatment in 1L metastatic TNBC, across PD-L1 status in Europe. In the U.S., Gilead has also submitted supplemental filings to the Food and Drug Administration (FDA) for Trodelvy for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy, or in combination with Keytruda or Keytruda Qlex in patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.

KEYTRUDA and KEYTRUDA QLEX are trademarks of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

About Triple-Negative Breast Cancer In Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitors

TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC.

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

Outside of Europe, Gilead has submitted supplemental applications to the U.S. Food and Drug Administration (FDA) for approval of Trodelvy based on the ASCENT-03 and ASCENT-04 studies.

Healthcare professionals have substantial clinical experience with Trodelvy, with more than 75,000 breast cancer patients treated since 2020. In addition to its first-line indication approval, Trodelvy is currently approved in more than 60 countries for patients with second-line or later mTNBC and in over 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer. It is the only ADC with four positive Phase 3 trials in HER2-negative metastatic breast cancer and the only Trop-2-directed ADC to demonstrate a meaningful overall survival benefit in two distinct types of metastatic breast cancer.

Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across different tumor types, including in small cell lung cancer and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

U.S. Indications for Trodelvy

TRODELVY (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
U.S. Important safety information FOR TRODELVY
BOXED WARNING: NEUTROPENIA AND DIARRHEA

TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

Please see full Prescribing Information, including BOXED WARNING.

(Press release, Gilead Sciences, JUN 23, 2026, View Source [SID1234668920])