Chemotherapy-induced nausea and vomiting

SAN DIEGO, Oct. 10, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today reaffirmed the Company's ability to supply CINVANTI® (aprepitant) injectable emulsion and SUSTOL® (granisetron) extended-release injection for Chemotherapy Induced Nausea and Vomiting ("CINV") prevention and APONVIE® for Postoperative Nausea and Vomiting ("PONV") prevention given the temporary shortage of intravenous ("IV") fluids which is expected as the result of Hurricane Helene. As alternatives to products that require dilution with IV fluids, CINVANTI, SUSTOL, and APONVIE are supplied in ready-to-administer formulations that do not require additional dilution with IV fluids in what may be a time of critical shortage. As widely reported, the potential disruption in the supply of intravenously administered fluids is a result of the temporary closure of a major suppliers' manufacturing site in Marion, North Carolina which was impacted by Hurricane Helene. The Marion facility is believed to supply up to 60% of the IV fluid market in the U.S. "In the wake of Hurricane Helene, and with the recently announced potential supply disruption for IV fluids, Heron has received outreach from several health systems preparing to maintain continuity of care," said Craig Collard, Chief Executive Officer of Heron. "Our team is committed to ensuring timely delivery of our products throughout the U.S. during the potential shortage of IV fluids as we understand the importance of preventing CINV and PONV for both patients and providers." CINVANTI, SUSTOL, and APONVIE are available through major wholesalers and specialty distributors, and further information can be obtained by calling the Company's information line at 844-HERON11 (844-437-6611). About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection. Please see full prescribing information at . About SUSTOL for CINV Prevention SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron's Biochronomer® drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL's efficacy and safety in more than 2,000 patients with cancer. SUSTOL's efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy). Please see full prescribing information at . About APONVIE for Postoperative Nausea and Vomiting (PONV) APONVIE is a substance NK1 Receptor Antagonist (RA), indicated for the prevention of PONV in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron's approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023. Please see full prescribing information at . About Heron Therapeutics, Inc. Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit . Forward-looking Statements This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding the potential market opportunities for APONVIE®, CINVANTI® and SUSTOL®. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law. Investor Relations and Media Contact: Ira Duarte Executive Vice President, Chief Financial Officer Heron Therapeutics, Inc. [email protected] 858-251-4400 SOURCE Heron Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NORTH READING, Mass.--( BUSINESS WIRE )--Aphios Corporation announced today that it has been granted Japanese Patent No. 7,520,838 for novel compositions to treat folic acid deficiency and morning sickness. The dosage forms have an effective amount of a folic acid, gingerols and shogaols to suppress nausea, relieve gastric distress and promote hematopoiesis. Pregnancy related nausea and vomiting (PRNV) is the most common medical condition during pregnancy. PRNV affects up to 70% of women during their first trimester, and many in the second and third trimester. The most serious form of PRNV is called Hyperemesis gravidarum (HG) that is reported in up to 10% of pregnant women. PRNV and HG affects women's quality of life and exerts a large economic impact on patients, caregivers and society. There are only a few medications approved by the FDA to treat and manage PRNV and HG. Folic acid deficiency can also have a significant impact on the health and welfare of newborns, parents, caregivers and society. Folic acid is necessary and critical to fetal development during pregnancy since it promotes DNA synthesis and cell division, affecting hematopoietic cells. In addition to folic acid, a number of medications that include folic acid have been used in the past to treat this deficiency during pregnancy. These supplements are also associated with nausea and upset stomach. There is thus a need to develop improved formulations which do not cause gastric distress and nausea. According to Dr. Trevor P. Castor, inventor of the patent, “These novel compositions impact high unmet needs to manage pregnancy related nausea and vomiting without synthetic drugs, while improving the health of the fetus and mother with folic acid supplements, managing any resulting gastric distress and improving hemostasis that is accomplished by both gingerols/shogaols and folic acid supplements.” About Aphios Corporation: Aphios is an emerging growth, green biotechnology company using earth-friendly supercritical fluids and nanotechnologies to develop enabling technology platforms. Based on these platforms and inspired by nature, we are developing enhanced therapeutics to maintain health, improve quality-of-life and treat chronic diseases including certain cancers and Zindol ® for chemotherapy induced nausea and vomiting (CINV), infectious diseases such as HIV/AIDS, influenza and COVID-19, and CNS disorders such as Alzheimer’s disease and opioid addiction in an environmentally sustainable manner.

FOSTER CITY, Calif.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) will present new data from the company’s broad lung cancer clinical development program during the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer, taking place Sept. 7-10, 2024 in San Diego, Calif. Data to be highlighted across three oral presentations include: initial results from two cohorts of the EVOKE-02 study of Trodelvy ® (sacituzumab govitecan-hziy) in previously untreated advanced or metastatic non-small cell lung cancer (mNSCLC), results from a subgroup analysis of the EVOKE-01 study of Trodelvy in second-line mNSCLC, and updated data from the TROPiCS-03 study of Trodelvy in extensive stage small cell lung cancer (ES-SCLC). New Findings Further Support the Potential Efficacy of Trodelvy for mNSCLC in the First-Line Setting Results to be presented from Cohorts C (non-squamous) and D (squamous) of the Phase 2 EVOKE-02 study of Trodelvy in previously untreated mNSCLC in combination with pembrolizumab and carboplatin demonstrate encouraging efficacy in patients with non-AGA-driven mNSCLC and across PD-L1 status. These additional findings advance our scientific understanding of the optimal treatment regimens and appropriate patient populations with mNSCLC that may potentially benefit from treatment with Trodelvy in the first-line setting. “ Our data at WCLC will add to the expanding evidence for the potential of Trodelvy in lung cancer and reinforce our confidence in our broader lung cancer strategy,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “ The totality of mature EVOKE-02 data suggest that in the first-line setting, Trodelvy in combination with pembrolizumab may have a greater potential to positively impact patients with mNSCLC when given without the addition of chemotherapy. These findings support the ongoing Phase 3 EVOKE-03 study and underscore our commitment to improving the standard of care for patients with lung cancer.” Analysis Shows Overall Survival (OS) Improvement with Trodelvy in a Subgroup of Second-Line mNSCLC Patients Additionally, Gilead will present data from the EVOKE-01 study in the subgroup of patients whose tumors did not respond to their last anti-PD-(L)1-therapy, building on the primary analysis presented earlier this year. Results from a pre-specified analysis showed a numerical OS improvement vs. docetaxel in this patient population, which was observed across histologies and regardless of whether patients were stable or progressed after their last anti-PD-(L)1-containing treatment. This subgroup analysis was not alpha-controlled for formal statistical testing. These meaningful data in mNSCLC help advance our understanding of Trodelvy’s potential for patients with lung cancer. Longer-Term Follow-up Data from the Phase 2 TROPiCS-03 ES-SCLC Cohort Demonstrate Promising Activity Gilead will also share updated results from the global Phase 2 TROPiCS-03 ES-SCLC Cohort. These new data, with additional patients and longer-term follow-up, reinforce promising activity shown with Trodelvy treatment in patients with both platinum-resistant and platinum-sensitive disease and support further investigation of Trodelvy in ES-SCLC, where there is still significant unmet need. Summary of Presentations Accepted abstracts at WCLC 2024 include: Date/Time Abstract September 8, 2:00 PM – 3:15 PM PT (Oral Presentation) Abstract #OA04.04: Sacituzumab Govitecan as Second-Line Treatment in Patients with Extensive Stage Small Cell Lung Cancer September 9, 10:45 AM – 12:00 PM PT (Oral Presentation) Abstract #OA08.07: Sacituzumab Govitecan + Pembrolizumab + Carboplatin in 1L Metastatic Non-Small Cell Lung Cancer: The EVOKE-02 Study September 9, 10:45 AM – 12:00 PM PT (Oral Presentation) Abstract #OA08.06: Sacituzumab Govitecan vs. Docetaxel in Patients With mNSCLC non-Responsive to Last anti-PD-(L)1–Containing Regimen: EVOKE-01 Trodelvy has not been approved by any regulatory agency for the treatment of mNSCLC or ES-SCLC. Its safety and efficacy have not been established for this use. Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; please see below for the approved U.S. Indications and Important Safety Information. About Trodelvy Trodelvy ® (sacituzumab govitecan-hziy) is a first-in-class 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, bladder 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. Trodelvy is approved in almost 50 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy is also approved to treat certain patients with pre-treated HR+/HER2- metastatic breast cancer in Australia, Brazil, Canada, the European Union, Israel, United Arab Emirates and the United States. In the U.S., Trodelvy has an accelerated approval for treatment of certain patients with second-line metastatic urothelial cancer; see below for full indication statements. Trodelvy is being explored for potential investigational use in other TNBC, HR+/HER2- and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, including mNSCLC, head and neck cancer, gynecological cancer, and gastrointestinal cancers. U.S. Indications for Trodelvy In the United States, Trodelvy is 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. Locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. U.S. Important Safety Information for Trodelvy BOXED WARNING: NEUTROPENIA AND DIARRHEA Severe or life-threatening neutropenia may occur. Withhold Trodelvy for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Consider G-CSF for secondary prophylaxis. Initiate anti-infective treatment in patients with febrile neutropenia without delay. Severe diarrhea may occur. 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 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%. Withhold Trodelvy for absolute neutrophil count below 1500/mm 3 on Day 1 of any cycle or neutrophil count below 1000/mm 3 on Day 8 of any cycle. Withhold Trodelvy for neutropenic fever. Administer G-CSF as clinically indicated or indicated in Table 1 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: Serious hypersensitivity reactions including life-threatening anaphylactic reactions have occurred with Trodelvy. 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: 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 NK 1 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. In the TROPHY study (locally advanced or metastatic urothelial cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, any infection, alopecia, decreased appetite, constipation, vomiting, rash, and abdominal pain. The most frequent serious adverse reactions (SAR) (≥5%) were infection (18%), neutropenia (12%, including febrile neutropenia in 10%), acute kidney injury (6%), urinary tract infection (6%), and sepsis or bacteremia (5%). SAR were reported in 44% of patients, and 10% discontinued due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPHY study were reduced neutrophils, leukocytes, and lymphocytes. 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. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Forward-Looking Statements This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Trodelvy (such as EVOKE-01, EVOKE-02 and TROPiCS-03); uncertainties relating to regulatory applications and related filing and approval timelines, including pending or potential applications for Trodelvy for the treatment of metastatic and other TNBC, HR+/HER2- metastatic breast cancer, mUC, metastatic NSCLC, head and neck cancer, gynecological cancer and gastrointestinal cancer; Gilead’s ability to receive regulatory approvals for programs and/or indications that are currently under evaluation in a timely manner or at all, and the risk that any such approvals may be subject to significant limitations on use and is subject to, withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaim any intent to update any such forward-looking statements. Trodelvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. U.S. Prescribing Information for Trodelvy, including BOXED WARNING , is available at www.gilead.com . For more information about Gilead, please visit the company’s website at www.gilead.com , follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).