Keytruda

wurde von der EMA in der EU und von der FDA in den USA für verschiedene Indikationen bereits zugelassen. Im hierauf folgenden EPAR-Bericht (Öffentlicher Beurteilungsbericht) der EMA kannst Du Dich über die aktuelle Zulassung in der EU informieren. In der Tabelle da drunter findest du Informationen zu den Zulassungen, zur Produktinformation in Deutsch (beinhaltet auch die Packungsbeilage und Indikationen) sowie Links zu den Seiten der EMA oder einer amerikanischen Seite (www.drug.com), die Dir alle Informationen zum Medikament in Englisch und mit Bezug zu den USA also der FDA zur Verfügung stellt. 

Öffentlicher Beurteilungsbericht

Marken
Name		Keytruda
Arzneimittel
Name 		Pembrolizumab
Therapie -KategorieAntikörper-Basierte-Therapie
WirkweiseCheckpoint Hemmer
Arzneimittel
Format		Monoklonaler Antikörper (mAb)
TargetPD-1; PD-L1
EMA
FirmaMerck Sharp & Dohme B.V.Merck Sharp & Dohme B.V.Merck Sharp & Dohme B.V.
Krebs-ArtBlasenBlutHaut
Krebs Art AbkürzungUCHMS
Therapeutische-Bezeichnung
-Karzinom		Harnwegs (UC)Blutkrebs (HM)Haut (S)
Karcinom-UntergruppeNZHodgkin´s Lymphom (HL)Melanom (M)
IndikationKEYTRUDA ist als Monotherapie zur Behandlung des lokal fortgeschrittenen oder metastasierenden Urothelkarzinoms
-nach vorheriger Platin-basierter Therapie bei Erwachsenen angezeigt.
-bei Erwachsenen, die nicht für eine Cisplatin-basierte Therapie geeignet sind und deren Tumoren PD-L1mit einem kombinierten positiven Score (CPS)≥10 exprimieren, angezeigt.		KEYTRUDA ist als Monotherapie zur Behandlung des rezidivierenden oder refraktären klassischen Hodgkin-Lymphoms (HL) bei Erwachsenen nach Versagen einer autologen Stammzelltransplantation (auto-SZT) und einer Behandlung mit Brentuximab Vedotin (BV), oder nach Versagen einer Behandlung mit BV, wenn eine auto-SZT nicht in Frage kommt, angezeigt.KEYTRUDA ist als Monotherapie zur Behandlung des fortgeschrittenen (nicht resezierbaren oder metastasierenden) Melanoms bei Erwachsenen angezeigt.
Medikamenten Information (Englisch)https://www.ema.europa.eu/en/medicines/human/EPAR/keytrudahttps://www.ema.europa.eu/en/medicines/human/EPAR/keytrudahttps://www.ema.europa.eu/en/medicines/human/EPAR/keytruda
EMA Produktinformationhttps://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_de.pdfhttps://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_de.pdfhttps://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_de.pdf
EMA Zustimmungs-Datum20.07.201723.03.201721.05.2015
EMA Markt -Zulassungs-Datum16.07.201516.07.201516.07.2015
Zulassungs-StatusZugelassenZugelassenZugelassen
EMA
FirmaMerck Sharp & Dohme B.V.Merck Sharp & Dohme B.V.Merck Sharp & Dohme B.V.
Krebs-ArtHautKopf; HalsLungen
Krebs Art AbkürzungSHNSCCNSCLC
Therapeutische-Bezeichnung
-Karzinom		Haut (S)Kopf und Hals Plattenepithel (HNSCC)Nichtkleinzelliges Bronchialkarzinom (NSCLC)
Karcinom-UntergruppeMelanom (M)NZNZ
IndikationKEYTRUDA ist als Monotherapie zur adjuvanten Behandlung des Melanomsim TumorstadiumIII mit Lymphknotenbeteiligung nach vollständiger Resektion bei Erwachsenen angezeigtKEYTRUDA ist als Monotherapie zur Behandlung des rezidivierenden oder metastasierenden Plattenepithelkarzinoms der Kopf-Hals-Region (HNSCC) mit PD-L1-exprimierenden Tumoren (TPS≥50%)und einem Fortschreiten der Krebserkrankung während oder nach vorheriger Platinbasierter Therapie bei Erwachsenen angezeigt.KEYTRUDA ist als Monotherapie zur Behandlung des lokal fortgeschrittenen oder metastasierenden NSCLC mit PD-L1-exprimierenden Tumoren(TPS≥1%) nach vorherigerChemotherapie bei Erwachsenen angezeigt. Patienten mit EGFR-oder ALK-positivenTumormutationensollten vor der Therapie mit KEYTRUDAebenfalls eine auf diese Mutationen zielgerichteteTherapie erhalten haben.
Medikamenten Information (Englisch)https://www.ema.europa.eu/en/medicines/human/EPAR/keytrudahttps://www.ema.europa.eu/en/medicines/human/EPAR/keytrudahttps://www.ema.europa.eu/en/medicines/human/EPAR/keytruda
EMA Produktinformationhttps://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_de.pdfhttps://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_de.pdfhttps://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_de.pdf
EMA Zustimmungs-Datum18.10.201826.07.201823.06.2016
EMA Markt -Zulassungs-Datum16.07.201516.07.201516.07.2015
Zulassungs-StatusZugelassenZugelassenZugelassen
EMA
FirmaMerck Sharp & Dohme B.V.Merck Sharp & Dohme B.V.Merck Sharp & Dohme B.V.
Krebs-ArtLungenLungenLungen
Krebs Art AbkürzungNSCLCNSCLCNSCLC
Therapeutische-Bezeichnung
-Karzinom		Nichtkleinzelliges Bronchialkarzinom (NSCLC)Nichtkleinzelliges Bronchialkarzinom (NSCLC)Nichtkleinzelliges Bronchialkarzinom (NSCLC)
Karcinom-UntergruppeNZNZNZ
IndikationKEYTRUDA ist als Monotherapie zur Erstlinienbehandlung des metastasierenden nicht-kleinzelligen Lungenkarzinoms (NSCLC) mit PD-L1-exprimierenden Tumoren (Tumor Proportion Score [TPS]≥50%) ohneEGFR-oder ALK-positive Tumormutationen bei Erwachsenen angezeigt.KEYTRUDA ist in Kombination mit Pemetrexed und Platin-Chemotherapie zur Erstlinienbehandlung des metastasierenden nicht-plattenepithelialen NSCLC ohne EGFR-oder ALK-positive Tumormutationen bei Erwachsenen angezeigt.KEYTRUDA ist in Kombination mit Carboplatin und entweder Paclitaxel oder nab-Paclitaxel zur Erstlinienbehandlung des metastasierenden plattenepithelialen NSCLC bei Erwachsenen angezeigt.
Medikamenten Information (Englisch)https://www.ema.europa.eu/en/medicines/human/EPAR/keytrudahttps://www.ema.europa.eu/en/medicines/human/EPAR/keytrudahttps://www.ema.europa.eu/en/medicines/human/EPAR/keytruda
EMA Produktinformationhttps://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_de.pdfhttps://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_de.pdfhttps://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_de.pdf
EMA Zustimmungs-Datum15.12.201626.07.201831.01.2019
EMA Markt -Zulassungs-Datum16.07.201516.07.201516.07.2015
Zulassungs-StatusZugelassenZugelassenZugelassen
EMA
FirmaMerck Sharp & Dohme B.V.
Krebs-ArtNieren
Krebs Art AbkürzungRCC
Therapeutische-Bezeichnung
-Karzinom		Nierenzell (RCC)
Karcinom-UntergruppeNZ
IndikationKeytruda, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults.
Medikamenten Information (Englisch)https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda
EMA Produktinformationhttps://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_de.pdf
EMA Zustimmungs-Datum25.07.2019
EMA Markt -Zulassungs-Datum16.07.2015
Zulassungs-StatusAusstehende EU-Entscheidung
FDA
FirmaMerck & Co IncMerck & Co IncMerck & Co Inc
Krebs-ArtBlasenBlutBlut
Krebs Art AbkürzungUCLYLY
Therapeutische-Bezeichnung
-Karzinom		Harnwegs (UC)Lymphom (LY)Lymphom (LY)
Karcinom-UntergruppeNZHodgkin´s Lymphom (HL)Mediastinale Großzellige B-Zell-Lymphom (PMBCL)
Indikationthe U.S. Food and Drug Administration (FDA) has approved two new indications for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.

In the first-line setting, Keytruda is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. 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 the confirmatory trials.

In the second-line setting, Keytruda is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Keytruda is approved for use in these indications at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.		the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy. Under the FDA’s accelerated approval regulations, this indication is approved based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.the U.S. Food and Drug Administration (FDA) has approved Keytruda, the company’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy.

This indication is approved under the FDA’s accelerated approval regulations based on tumor response rate and durability of response.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Keytruda is not recommended for the treatment of patients with PMBCL who require urgent cytoreductive therapy.
With this indication, Keytruda becomes the first anti-PD-1 therapy to be approved for the treatment of PMBCL, a type of non-Hodgkin lymphoma.
This is the second indication for Keytruda for the treatment of a hematologic malignancy.
Medikamenten Information (Englisch)https://www.drugs.com/newdrugs/fda-approves-merck-s-keytruda-pembrolizumab-certain-patients-locally-advanced-metastatic-urothelial-4536.htmlhttps://www.drugs.com/newdrugs/fda-approves-merck-s-keytruda-pembrolizumab-classical-hodgkin-lymphoma-chl-4497.htmlhttps://www.drugs.com/newdrugs/fda-approves-keytruda-pembrolizumab-refractory-relapsed-primary-mediastinal-large-b-cell-lymphoma-4767.html
Weitere Links (Englisch)(Leer)(Leer)(Leer)
FDA Zulassungs Historie (Englisch)https://www.drugs.com/history/keytruda.htmlhttps://www.drugs.com/history/keytruda.htmlhttps://www.drugs.com/history/keytruda.html
FDA Zulassungs-Jahr18.05.201714.05.201713.06.2018
Zulassungs-StatusZugelassenZugelassenZugelassen
FDA
FirmaMerck & Co IncMerck & Co IncMerck & Co Inc
Krebs-ArtDickdarm; RektumFeste TumorenFeste Tumoren
Krebs Art AbkürzungCRCdMMRMSI-H
Therapeutische-Bezeichnung
-Karzinom		Kolorektales (CRC)Solide Tumoren mit einem Biomarker der als Mismatch Repair Deficient definiert ist(dMMR)Solide Tumoren mit einem Biomarker der als Microsatellite Instability-High definiert ist(MSI-H)
Karcinom-UntergruppeNZNZNZ
IndikationThe U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.

Keytruda (pembrolizumab) is indicated for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options
and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs.		The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.

Keytruda (pembrolizumab) is indicated for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options
and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs.		The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker).
This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.

Keytruda (pembrolizumab) is indicated for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options
and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs.
Medikamenten Information (Englisch)https://www.drugs.com/newdrugs/fda-approves-keytruda-pembrolizumab-first-cancer-any-solid-tumor-specific-genetic-feature-4538.htmlhttps://www.drugs.com/newdrugs/fda-approves-keytruda-pembrolizumab-first-cancer-any-solid-tumor-specific-genetic-feature-4538.htmlhttps://www.drugs.com/newdrugs/fda-approves-keytruda-pembrolizumab-first-cancer-any-solid-tumor-specific-genetic-feature-4538.html
Weitere Links (Englisch)(Leer)(Leer)(Leer)
FDA Zulassungs Historie (Englisch)https://www.drugs.com/history/keytruda.htmlhttps://www.drugs.com/history/keytruda.htmlhttps://www.drugs.com/history/keytruda.html
FDA Zulassungs-Jahr23.05.201723.05.201723.05.2017
Zulassungs-StatusZugelassenZugelassenZugelassen
FDA
FirmaMerck & Co IncMerck & Co IncMerck & Co Inc
Krebs-ArtGebärmutterHautHaut
Krebs Art AbkürzungCCSS
Therapeutische-Bezeichnung
-Karzinom		Gebärmutter CC)Haut (S)Haut (S)
Karcinom-UntergruppeNZMelanom (M)Melanom (M)
Indikationthe U.S. Food and Drug Administration (FDA) has approved Keytruda, the company’s anti-PD-1 therapy, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. This indication is approved under the FDA’s accelerated approval regulations based on tumor response rate and durability of response.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.		the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection based on results from the EORTC1325/KEYNOTE-054 trial.he U.S. Food and Drug Administration (FDA) has approved an expanded indication for Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, to include the first-line treatment of patients with unresectable or metastatic melanoma.
Medikamenten Information (Englisch)https://www.drugs.com/newdrugs/fda-approves-keytruda-pembrolizumab-previously-treated-patients-recurrent-metastatic-cervical-4764.htmlhttps://www.drugs.com/newdrugs/fda-approves-keytruda-pembrolizumab-adjuvant-patients-melanoma-involvement-lymph-node-s-following-4918.htmlhttps://www.drugs.com/newdrugs/fda-approves-expanded-indication-keytruda-pembrolizumab-patients-advanced-melanoma-4319.html
Weitere Links (Englisch)(Leer)(Leer)(Leer)
FDA Zulassungs Historie (Englisch)https://www.drugs.com/history/keytruda.htmlhttps://www.drugs.com/history/keytruda.htmlhttps://www.drugs.com/history/keytruda.html
FDA Zulassungs-Jahr12.06.201819.02.201918.12.2015
Zulassungs-StatusZugelassenZugelassenZugelassen
FDA
FirmaMerck & Co IncMerck & Co IncMerck & Co Inc
Krebs-ArtHautHautKopf; Hals
Krebs Art AbkürzungSSHNSCC
Therapeutische-Bezeichnung
-Karzinom		Haut (S)Haut (S)Kopf und Hals Plattenepithel (HNSCC)
Karcinom-UntergruppeMelanom (M)Merkel Zell (MCC)NZ
IndikationThe U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC), based on the results of the Cancer Immunotherapy Trials Network (CITN)’s CITN-09/KEYNOTE-017 trial.

This indication is approved under accelerated approval based on tumor response rate and durability of response.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.		the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200 mg every three weeks, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Under the FDA’s accelerated approval regulations, this indication for Keytruda is approved based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. For HNSCC patients, PD-L1 testing is not needed prior to use of Keytruda.
Medikamenten Information (Englisch)https://www.drugs.com/newdrugs/fda-approves-keytruda-pembrolizumab-advanced-melanoma-4079.htmlhttps://www.drugs.com/newdrugs/fda-approves-keytruda-pembrolizumab-patients-recurrent-locally-advanced-metastatic-merkel-cell-4888.htmlhttps://www.drugs.com/newdrugs/fda-approves-merck-s-keytruda-pembrolizumab-patients-recurrent-metastatic-head-neck-squamous-cell-4419.html
Weitere Links (Englisch)(Leer)(Leer)(Leer)
FDA Zulassungs Historie (Englisch)https://www.drugs.com/history/keytruda.htmlhttps://www.drugs.com/history/keytruda.htmlhttps://www.drugs.com/history/keytruda.html
FDA Zulassungs-Jahr04.09.201419.12.201805.08.2016
Zulassungs-StatusZugelassenZugelassenZugelassen
FDA
FirmaMerck & Co IncMerck & Co IncMerck & Co Inc
Krebs-ArtLeberLungenLungen
Krebs Art AbkürzungHCCNSCLCNSCLC
Therapeutische-Bezeichnung
-Karzinom		Leberzell (HCC)Nichtkleinzelliges Bronchialkarzinom (NSCLC)Nichtkleinzelliges Bronchialkarzinom (NSCLC)
Karcinom-UntergruppeNZNicht Plattenepitheliales Nichtkleinzelliges Bronchialkarzinom (nsNSCLC)NZ
Indikationthe U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.the U.S. Food and Drug Administration (FDA) has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, in combination with pemetrexed (Alimta®) and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations, based on results of the KEYNOTE-189 trial.the U.S. Food and Drug Administration (FDA) has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
Medikamenten Information (Englisch)https://www.drugs.com/newdrugs/fda-approves-keytruda-pembrolizumab-patients-hepatocellular-carcinoma-hcc-have-been-previously-4863.htmlhttps://www.drugs.com/newdrugs/fda-approves-expanded-label-merck-s-keytruda-pembrolizumab-patients-metastatic-nonsquamous-nsclc-no-4805.htmlhttps://www.drugs.com/newdrugs/fda-approves-expanded-monotherapy-label-merck-s-keytruda-pembrolizumab-first-line-nsclc-4949.html
Weitere Links (Englisch)(Leer)(Leer)(Leer)
FDA Zulassungs Historie (Englisch)https://www.drugs.com/history/keytruda.htmlhttps://www.drugs.com/history/keytruda.htmlhttps://www.drugs.com/history/keytruda.html
FDA Zulassungs-Jahr09.11.201820.08.201811.04.2019
Zulassungs-StatusZugelassenZugelassenZugelassen
FDA
FirmaMerck & Co IncMerck & Co IncMerck & Co Inc
Krebs-ArtLungenLungenLungen
Krebs Art AbkürzungNSCLCNSCLCNSCLC
Therapeutische-Bezeichnung
-Karzinom		Nichtkleinzelliges Bronchialkarzinom (NSCLC)Nichtkleinzelliges Bronchialkarzinom (NSCLC)Nichtkleinzelliges Bronchialkarzinom (NSCLC)
Karcinom-UntergruppeNZNZNZ
Indikationthe U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, in combination with pemetrexed (brand name Alimta®) and carboplatin (pem/carbo), a commonly used chemotherapy regimen, for the first-line treatment of metastatic nonsquamous NSCLC, irrespective of PD-L1 expression. Under the FDA’s accelerated approval regulations, this indication is approved based on tumor response rate and progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.
Medikamenten Information (Englisch)https://www.drugs.com/newdrugs/fda-approves-merck-s-keytruda-pembrolizumab-first-line-certain-patients-metastatic-non-small-cell-4449.htmlhttps://www.drugs.com/newdrugs/fda-approves-merck-s-keytruda-pembrolizumab-first-line-combination-therapy-patients-metastatic-4533.htmlhttps://www.drugs.com/newdrugs/fda-approves-keytruda-pembrolizumab-advanced-non-small-cell-lung-cancer-4273.html
Weitere Links (Englisch)(Leer)(Leer)(Leer)
FDA Zulassungs Historie (Englisch)https://www.drugs.com/history/keytruda.htmlhttps://www.drugs.com/history/keytruda.htmlhttps://www.drugs.com/history/keytruda.html
FDA Zulassungs-Jahr24.10.201610.05.201702.10.2015
Zulassungs-StatusZugelassenZugelassenZugelassen
FDA
FirmaMerck & Co IncMerck & Co IncMerck & Co Inc
Krebs-ArtLungenMagenNieren
Krebs Art AbkürzungNSCLCGCRCC
Therapeutische-Bezeichnung
-Karzinom		Nichtkleinzelliges Bronchialkarzinom (NSCLC)Magen (GC)Nierenzell (RCC)
Karcinom-UntergruppePlattenepitheliales Nichtkleinzelliges Bronchialkarzinom (sNSCLC)Magenkarzinom (GC) oder Speiseröhren Adenokarzinom (GEJ)NZ
IndikationThe U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) based on results from the KEYNOTE-407 trial.the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.

This indication is approved under the FDA’s accelerated approval regulations based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.		the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Medikamenten Information (Englisch)https://www.drugs.com/newdrugs/fda-approves-keytruda-pembrolizumab-combination-carboplatin-either-paclitaxel-nab-paclitaxel-first-4853.htmlhttps://www.drugs.com/newdrugs/fda-approves-merck-s-keytruda-pembrolizumab-previously-treated-patients-recurrent-locally-advanced-4605.htmlhttps://www.drugs.com/newdrugs/fda-approves-merck-s-keytruda-pembrolizumab-combination-inlyta-axitinib-first-line-patients-4956.html
Weitere Links (Englisch)(Leer)(Leer)(Leer)
FDA Zulassungs Historie (Englisch)https://www.drugs.com/history/keytruda.htmlhttps://www.drugs.com/history/keytruda.htmlhttps://www.drugs.com/history/keytruda.html
FDA Zulassungs-Jahr30.10.201822.09.201722.04.2019
Zulassungs-StatusZugelassenZugelassenZugelassen

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