{"id":26209,"date":"2026-06-25T15:45:00","date_gmt":"2026-06-25T13:45:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=8d83aa14a203629f5ed5b558a8c5af17"},"modified":"2026-06-25T15:45:00","modified_gmt":"2026-06-25T13:45:00","slug":"fda-approves-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-trodelvy-sacituzumab-govitecan-hziy-as-first-line-treatment-of","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=26209","title":{"rendered":"FDA Approves KEYTRUDA\u00ae (pembrolizumab) and KEYTRUDA QLEX\u2122 (pembrolizumab and berahyaluronidase alfa-pmph), each with Trodelvy\u00ae (sacituzumab govitecan-hziy) as First-Line Treatment of PD-L1+ (CPS \u226510) Advanced Triple-Negative Breast Cancer (TNBC)"},"content":{"rendered":"

\nFirst approval of PD\u20111 inhibitors in combination with a Trop-2-directed antibody-drug conjugate (ADC) in advanced TNBC, marking a potentially practice\u2011changing treatment option<\/b><\/p>

RAHWAY, N.J.--(BUSINESS WIRE)--$MRK<\/a> #MRK<\/a>--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA\u00ae <\/sup>(pembrolizumab) and KEYTRUDA QLEX\u2122 (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Trodelvy\u00ae <\/sup>(sacituzumab govitecan-hziy), Gilead\u2019s Trop-2-directed antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] \u226510) as determined by an FDA-authorized test. These approvals represent the first PD-1 inhibitors plus Trop-2-directed ADC regimen in advanced TNBC.<\/p><\/a><\/a>

\nThese approvals are based on data from the Phase 3 KEYNOTE-D19\/ASCENT-04 trial demonstrating that KEYTRUDA plus Trodelvy reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.51-0.84]; p=0.0009) versus KEYTRUDA plus chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine and carboplatin) for the first-line treatment of adult patients with PD-L1+ (CPS \u226510) unresectable locally advanced or metastatic TNBC. KEYTRUDA plus Trodelvy resulted in a median progression-free survival (PFS) of 11.2 months [95% CI, 9.3-16.7] versus 7.8 months [95% CI, 7.3-9.3] with KEYTRUDA plus chemotherapy. The objective response rate (ORR) was higher with KEYTRUDA plus Trodelvy (61% [95% CI, 55-68]) than with KEYTRUDA plus chemotherapy (55% [95% CI, 48-62]), and complete responses occurred in 12% and 8% of patients, respectively. The effectiveness of KEYTRUDA QLEX for its approved indications has been established based upon evidence from the adequate and well-controlled studies conducted with KEYTRUDA and additional data from MK\u20113475A\u2011D77 comparing the pharmacokinetic, efficacy and safety profiles of KEYTRUDA QLEX and KEYTRUDA.<\/p>

\n\u201cFor people living with metastatic triple-negative breast cancer, the first treatment choice can be pivotal, as many patients may not have the opportunity to receive subsequent therapies,\u201d said Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute and a principal investigator of Merck\u2019s KEYNOTE-D19 and Gilead\u2019s ASCENT-04 study. \u201cThese approvals are heartening news for patients and the clinical community, and I believe offer practice-changing first-line treatment options.\u201d<\/p>

\nKEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. KEYTRUDA and KEYTRUDA QLEX are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions in any or multiple organs, which can occur during or after treatment, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, other transplant (including corneal graft) rejection; severe and life-threatening infusion or injection-related reactions; fatal and other serious complications in patients who receive allogeneic hematopoietic stem cell transplantation before or after beginning treatment; embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when KEYTRUDA or KEYTRUDA QLEX is added to a thalidomide analogue plus dexamethasone, which is not recommended outside of controlled trials. Immune-mediated adverse reactions listed here may not include all such possible severe or fatal reactions. For more information, see \u201cSelected Important Safety Information\u201d below.<\/p>

\n\u201cPatients with PD-L1+ unresectable locally advanced or metastatic TNBC have limited treatment options in the first-line setting, as this aggressive disease often advances quickly,\u201d said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. \u201cWe now have new first-line treatment options that combine, for the first time, a PD-1 inhibitor with a Trop-2-directed ADC, and significantly reduce disease progression or death compared to KEYTRUDA plus chemotherapy. Today\u2019s approvals of KEYTRUDA and KEYTRUDA QLEX each in combination with Trodelvy represent a meaningful milestone for those living with advanced TNBC.\u201d<\/p>

\nPembrolizumab (KEYTRUDA\u00ae<\/sup>) in combination with sacituzumab govitecan-hziy (Trodelvy\u00ae<\/sup>) is recommended by the National Comprehensive Cancer Network\u00ae<\/sup> (NCCN\u00ae<\/sup>) Clinical Practice Guidelines in Oncology (NCCN Guidelines\u00ae<\/sup>) for Breast Cancer as a category 1 <\/sup>preferred first-line treatment option for certain patients with recurrent unresectable (local or regional) or stage IV (M1) triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS \u226510).*<\/p>

\n\u201cFor appropriate patients with metastatic TNBC, a new first\u2011line treatment option offers optimism to a community with historically few choices,\u201d said Ricki Fairley, co\u2011founder and CEO of TOUCH, The Black Breast Cancer Alliance. \u201cTNBC disproportionately affects younger women \u2013 many in the prime of their lives \u2013 and often leads to poorer outcomes. Because so many patients may never receive subsequent lines of therapy, the ability to start with options like Trodelvy with or without KEYTRUDA or KEYTRUDA QLEX is critical. We have sought additional alternatives to chemotherapy-containing regimens in the first-line metastatic setting since TNBC was classified as a disease more than 20 years ago. As such, these approvals represent meaningful progress for the families impacted by this disease.\u201d<\/p>

\nThe median duration of exposure to KEYTRUDA was 8.5 months (range 1 day to 26.8 months).<\/p>

\nFatal adverse reactions occurred in 3.2% of patients receiving KEYTRUDA in combination with sacituzumab govitecan-hziy, including death due to unknown cause (0.9%), and completed suicide, neutropenic sepsis, sepsis, pneumonia and pulmonary embolism (0.5% each).<\/p>

\nSerious adverse reactions occurred in 38% of patients receiving KEYTRUDA in combination with sacituzumab govitecan-hziy. Serious adverse reactions in \u22652% of patients were febrile neutropenia (7%), neutropenia (6%), diarrhea (5%), fatigue and pneumonia (2.3% each).<\/p>

\nPermanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 9% of patients. The adverse reactions which resulted in permanent discontinuation of KEYTRUDA most commonly (\u22651%) were pneumonitis and rash (1.4% each).<\/p>

\nDosage interruptions of KEYTRUDA due to adverse reactions occurred in 67% of patients. Adverse reactions which required dosage interruption in \u22652% of patients included neutropenia (36%), diarrhea (7%), upper respiratory tract infection (4.5%), anemia (4.1%), fatigue (4.1%), increased alanine aminotransferase (ALT) (3.2%), cough (2.7%), leukopenia (2.7%), nausea (2.7%), pyrexia (2.7%), rash (2.7%), vomiting (2.7%) and COVID-19 (2.3%).<\/p>

\nThe most common (\u226525%) adverse reactions, including laboratory abnormalities, occurring in patients treated with KEYTRUDA in combination with sacituzumab govitecan-hziy were decreased neutrophil count and decreased hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and increased glucose (50% each), increased ALT (47%), constipation (41%), increased aspartate aminotransferase (40%), rash (37%), decreased potassium (35%), increased lactate dehydrogenase (34%), vomiting (29%), abdominal pain, headache, and increased eosinophils (26% each) and decreased albumin (25%).<\/p>

\n*According to the NCCN Guidelines (Version 4.2026<\/a>), category 1 is based upon high-level evidence (\u22651 randomized phase 3 trials or high-quality, robust meta-analyses), there is uniform NCCN consensus (\u226585% support of the Panel) that the intervention is appropriate. Preferred intervention refers to interventions that are based on superior efficacy, safety, and evidence; and, when appropriate, affordability. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.<\/p>

\nAbout KEYNOTE-D19\/ASCENT-04<\/b><\/p>

\nKEYNOTE-D19\/ASCENT-04 (ClinicalTrials.gov, NCT05382286<\/a>) is a Phase 3 multicenter, open-label, randomized, active-controlled trial evaluating KEYTRUDA in combination with sacituzumab govitecan-hziy in patients with unresectable locally advanced or metastatic TNBC, who had not been previously treated with systemic therapy for advanced disease and whose tumors expressed PD-L1 (CPS \u226510) according to the PD-L1 IHC 22C3 pharmDx assay. The primary efficacy endpoint was progression-free survival (PFS) as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Secondary efficacy endpoints included overall survival (OS) and objective response rate (ORR) as assessed by BICR using RECIST v1.1. Safety also was evaluated. The study enrolled 443 patients who were randomized 1:1 to receive either KEYTRUDA (200 mg intravenously [IV] on Day 1 of each 21-day cycle) plus sacituzumab govitecan-hziy (10 mg\/kg IV on Days 1 and 8 of each 21-day cycle) (n=221) or KEYTRUDA (200 mg IV on Day 1 of each 21-day cycle) plus chemotherapy (n=222). The chemotherapy regimen included gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel.<\/p>

\nAssessment of tumor status was performed every 8 weeks for the first 18 months, and every 12 weeks thereafter. Treatment beyond BICR-verified disease progression per RECIST 1.1 was permitted if the patient was clinically stable and considered to be deriving clinical benefit by the investigator. Crossover to sacituzumab govitecan-hziy monotherapy was offered following disease progression and study treatment discontinuation.<\/p>

\nAbout triple-negative breast cancer (TNBC)<\/b><\/p>

\nTriple-negative breast cancer is an aggressive type of breast cancer; it has the highest risk of recurrence within the first five years after treatment and is associated with worse outcomes compared to other forms of breast cancer. Approximately 10-15% of patients with breast cancer are diagnosed with TNBC. While some breast cancers may test positive for estrogen receptors (ER), progesterone receptors (PR) or overexpression of human epidermal growth factor receptor 2 (HER2), TNBC tests negative for ER and PR, and does not overexpress HER2. Triple-negative breast cancer tends to be more common in people who are younger than age 40, who are Black or who have certain gene mutations.<\/p>

\nAbout KEYTRUDA\u00ae<\/sup> (pembrolizumab) injection for intravenous use, 100 mg<\/b><\/p>

\nKEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body\u2019s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.<\/p>

\nMerck has the industry\u2019s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.<\/p>

\nAbout KEYTRUDA QLEX\u2122 (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use, 165 mg + 2,000 units\/mL<\/b><\/p>

\nKEYTRUDA QLEX is a fixed-combination drug product of pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody and berahyaluronidase alfa enhances dispersion and permeability to enable subcutaneous administration of pembrolizumab. KEYTRUDA QLEX is administered as a subcutaneous injection into the thigh or abdomen, avoiding the 5 cm area around the navel, over one minute every three weeks (2.4 mL) or over two minutes every six weeks (4.8 mL). KEYTRUDA QLEX must be administered by a healthcare provider.<\/p>

\nSelected Indications in the U.S. for KEYTRUDA\u00ae<\/sup> (pembrolizumab) and KEYTRUDA QLEX\u2122 (pembrolizumab and berahyaluronidase alfa-pmph)<\/b><\/p>

\nTriple-Negative Breast Cancer<\/i><\/p>

\nKEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then each continued as a single agent as adjuvant treatment after surgery.<\/p>

\nKEYTRUDA and KEYTRUDA QLEX, each in combination with sacituzumab govitecan-hziy, are indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS \u226510) as determined by an FDA-authorized test.<\/p>

\nKEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with chemotherapy, for the treatment of adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS \u226510) as determined by an FDA-authorized test.<\/p>

\nSee additional selected indications for KEYTRUDA and KEYTRUDA QLEX in the U.S. after the Selected Safety Information.<\/i><\/p>

\nSelected Safety Information for KEYTRUDA and KEYTRUDA QLEX<\/b><\/p>

\nContraindications<\/b><\/p>

\nKEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients.<\/p>

\nSevere and Fatal Immune-Mediated Adverse Reactions<\/b><\/p>

\nKEYTRUDA and KEYTRUDA QLEX are monoclonal antibodies that belong to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1\/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.<\/p>

\nMonitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti\u2013PD-1\/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA or KEYTRUDA QLEX in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.<\/p>

\nWithhold or permanently discontinue KEYTRUDA and KEYTRUDA QLEX depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA and KEYTRUDA QLEX require interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg\/kg\/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.<\/p>

\nImmune-Mediated Pneumonitis<\/span><\/p>

\nKEYTRUDA and KEYTRUDA QLEX can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94\/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63\/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Immune-mediated pneumonitis occurred in 5% (13\/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including fatal (0.4%), Grade 3 (2%), and Grade 2 (1.2%) adverse reactions.<\/p>

\nPneumonitis occurred in 7% (41\/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.<\/p>

\nImmune-Mediated Colitis<\/span><\/p>

\nKEYTRUDA and KEYTRUDA QLEX can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection\/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.<\/p>

\nImmune-mediated colitis occurred in 1.7% (48\/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33\/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients. Immune-mediated colitis occurred in 1.2% (3\/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including Grade 3 (0.8%) and Grade 2 (0.4%) adverse reactions.<\/p>

\nHepatotoxicity and Immune-Mediated Hepatitis<\/span><\/p>

\nKEYTRUDA and KEYTRUDA QLEX can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19\/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13\/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients. Immune-mediated hepatitis occurred in 0.4% (1\/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including Grade 2 (0.4%) adverse reactions.<\/p>

\nKEYTRUDA With Axitinib or KEYTRUDA QLEX With Axitinib<\/i><\/p>

\nKEYTRUDA and KEYTRUDA QLEX, when either is used in combination with axitinib, can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib or KEYTRUDA QLEX and axitinib, and consider administering corticosteroids as needed.<\/p>

\nWith the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT \u22653 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT \u22653 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT \u22653 ULN subsequently recovered from the event.<\/p>

\nImmune-Mediated Endocrinopathies<\/span><\/p>

\nAdrenal Insufficiency<\/i><\/p>

\nKEYTRUDA and KEYTRUDA QLEX can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA and KEYTRUDA QLEX depending on severity. Adrenal insufficiency occurred in 0.8% (22\/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17\/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Adrenal insufficiency occurred in 2% (5\/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including Grade 3 (0.4%) and Grade 2 (0.8%) adverse reactions.<\/p>

\nHypophysitis<\/i><\/p>

\nKEYTRUDA and KEYTRUDA QLEX can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA and KEYTRUDA QLEX depending on severity.<\/p>

\nHypophysitis occurred in 0.6% (17\/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16\/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.<\/p>

\nThyroid Disorders<\/i><\/p>

\nKEYTRUDA and KEYTRUDA QLEX can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA and KEYTRUDA QLEX depending on severity.<\/p>

\nThyroiditis occurred in 0.6% (16\/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.<\/p>

\nHyperthyroidism occurred in 3.4% (96\/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237\/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.<\/p> Contacts<\/b>

\nMedia Contacts:\nJulie Cunningham\n(617) 519-6264<\/p>

\nDiane Foley\n(862) 260-0060<\/p>

\nInvestor Contacts:\nPeter Dannenbaum\n(732) 594-1579<\/p>

\nSteven Graziano\n(732) 594-1583<\/p> Read full story here <\/a>","protected":false},"excerpt":{"rendered":"

First approval of PD\u20111 inhibitors in combination with a Trop-2-directed antibody-drug conjugate (ADC) in advanced TNBC, marking a potentially practice\u2011changing treatment optionRAHWAY, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD o…<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-26209","post","type-post","status-publish","format-standard","hentry","category-infos-businesswire"],"_links":{"self":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/26209","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=26209"}],"version-history":[{"count":1,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/26209\/revisions"}],"predecessor-version":[{"id":26210,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/26209\/revisions\/26210"}],"wp:attachment":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=26209"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=26209"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=26209"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}