FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With Padcev® (enfortumab vedotin-ejfv), as Treatment Before and After Surgery for Adults With Muscle-Invasive Bladder Cancer (MIBC)
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| Title: | FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With Padcev® (enfortumab vedotin-ejfv), as Treatment Before and After Surgery for Adults With Muscle-Invasive Bladder Cancer (MIBC) |
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| Authors: | Merck & Co., Inc. |
| Source: | Business Wire (English). 07/10/2026. |
| Abstract: | 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® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapies, each in combination with Padcev® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). These approvals represent the first and only PD-1 inhibitor plus antibody-drug conjugate (ADC) regimens approved for adults with MIBC regardless of cisplatin eligibility. [ABSTRACT FROM PUBLISHER] |
| Database: | Regional Business News |
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| Header | DbId: bwh DbLabel: Regional Business News An: bizwire.20260710192353 AccessLevel: 6 PubType: News PubTypeId: newspaperArticle PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With Padcev® (enfortumab vedotin-ejfv), as Treatment Before and After Surgery for Adults With Muscle-Invasive Bladder Cancer (MIBC) – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Merck+%26+Co%2E%2C+Inc%2E%22">Merck & Co., Inc.</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Business+Wire+%28English%29%22">Business Wire (English)</searchLink>. 07/10/2026. – Name: Abstract Label: Abstract Group: Ab Data: 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® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapies, each in combination with Padcev® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). These approvals represent the first and only PD-1 inhibitor plus antibody-drug conjugate (ADC) regimens approved for adults with MIBC regardless of cisplatin eligibility. [ABSTRACT FROM PUBLISHER] |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=bwh&AN=bizwire.20260710192353 |
| RecordInfo | BibRecord: BibEntity: Languages: – Code: eng Text: English Titles: – TitleFull: FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With Padcev® (enfortumab vedotin-ejfv), as Treatment Before and After Surgery for Adults With Muscle-Invasive Bladder Cancer (MIBC) Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Merck & Co., Inc. IsPartOfRelationships: – BibEntity: Dates: – D: 10 M: 07 Text: 07/10/2026 Type: published Y: 2026 Titles: – TitleFull: Business Wire (English) Type: main |
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