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News about "pembrolizumab "
EU Expands Trodelvy Use in First-Line Metastatic Triple-Negative Breast Cancer
The European Commission (EC) approves Trodelvy plus pembrolizumab for first-line PD-L1-positive metastatic Triple-Negative Breast Cancer (TNBC), expanding its use across PD-L1 status.
Pembrolizumab | 25/08/2026 | By News Bureau
BioInvent's BI-1808 Receives FDA Fast Track Designation for Ovarian Cancer
BioInvent’s BI-1808 has received FDA Fast Track Designation for ovarian cancer, supporting accelerated development of the investigational anti-TNFR2 therapy in combination with pembrolizumab.
Pembrolizumab | 11/08/2026 | By News Bureau
PD-L1 IHC 22C3 pharmDx gains CE-marked indication to identify eligible patients with epithelial ovarian, fallopian tube and primary peritoneal carcinoma for pembrolizumab treatment.
Pembrolizumab | 27/07/2026 | By News Bureau
US FDA Approves PADCEV Plus Keytruda for Muscle-Invasive Bladder Cancer
The US Food and Drug Administration (FDA) has approved PADCEV plus Keytruda as the first and only platinum-free neoadjuvant and adjuvant treatment for adults with Muscle-Invasive Bladder Cancer (MIBC), regardless of cisplatin eligibility.
Pembrolizumab | 13/07/2026 | By News Bureau | 107
US FDA Approves KEYTRUDA and KEYTRUDA QLEX, Each with Trodelvy
The US Food and Drug Administration (FDA) has approved KEYTRUDA and KEYTRUDA QLEX in combination with Trodelvy as first-line treatment for adults with PD-L1-positive (CPS ≥10) advanced Triple-Negative Breast Cancer (TNBC).
Pembrolizumab | 26/06/2026 | By News Bureau | 196
US FDA Approves KEYTRUDA-WELIREG Combination for Adjuvant ccRCC
The US Food and Drug Administration (FDA) has approved KEYTRUDA and KEYTRUDA QLEX in combination with WELIREG for the adjuvant treatment of certain patients with clear cell Renal Cell Carcinoma (ccRCC). The approval expands treatment options for kidney cancer patients at high risk of recurrence following surgery.
Pembrolizumab | 15/06/2026 | By News Bureau
US FDA Grants Breakthrough Therapy Designation to Calderasib for KRAS G12C-Mutant NSCLC
Calderasib has received US FDA Breakthrough Therapy Designation for certain patients with newly diagnosed metastatic KRAS G12C-mutant Non-Small Cell Lung Cancer (NSCLC), supported by promising phase 1 KANDLELIT-001 trial data highlighting its potential as a next-generation, highly potent and selective KRAS G12C inhibitor.
Pembrolizumab | 30/05/2026 | By News Bureau | 137
Samsung Bioepis achieves positive Phase 1 results for Keytruda biosimilar candidate SB27
The biopharmaceutical company announced that its proposed pembrolizumab biosimilar, SB27, met primary pharmacokinetic endpoints in a global Phase 1 study involving non-small cell lung cancer patients, advancing its oncology biosimilar pipeline.
Pembrolizumab | 08/05/2026 | By News Bureau | 218
Zydus Partners with Bioeq for US Commercialisation of Lucentis Biosimilar
Zydus has entered into a partnership with Bioeq to commercialise NUFYMCO, an interchangeable biosimilar to Lucentis, in the US market. Under the agreement, Bioeq will handle development, manufacturing, regulatory approval and product supply, while Zydus will oversee US commercialisation.
Pembrolizumab | 24/12/2025 | By News Bureau | 205
KEYTRUDA Plus Padcev Improves Survival Outcomes in MIBC
KEYTRUDA plus Padcev significantly improved survival and pathologic complete response rates in cisplatin-eligible patients with muscle-invasive bladder cancer when used before and after surgery.
Pembrolizumab | 18/12/2025 | By News Bureau | 220
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