|
1 Indications And Usage Tecentriq Is A Programmed Death-Ligand 1 (Pd-L1) Blocking Antibody Indicated: Urothelial Carcinoma For The Treatment Of Adult Patients With Locally Advanced Or Metastatic Urothelial Carcinoma Who: Are Not Eligible For Cisplatin-Containing Chemotherapy And Whose Tumors Express Pd-L1 (Pd-L1 Stained Tumor-Infiltrating Immune Cells [Ic] Covering ≥ 5% Of The Tumor Area), As Determined By An Fda-Approved Test, Or Are Not Eligible For Any Platinum-Containing Chemotherapy Regardless Of Pd-L1 Status, Or Have Disease Progression During Or Following Any Platinum-Containing Chemotherapy, Or Within 12 Months Of Neoadjuvant Or Adjuvant Chemotherapy. ( 1.1 ) 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 A Confirmatory Trial(S). ( 1.1 ) Non-Small Cell Lung Cancer (Nsclc) For The First-Line Treatment Of Adult Patients With Metastatic Nsclc Whose Tumors Have High Pd-L1 Expression (Pd-L1 Stained ≥ 50% Of Tumor Cells [Tc ≥ 50%] Or Pd-L1 Stained Tumor-Infiltrating Immune Cells [Ic] Covering ≥ 10% Of The Tumor Area [Ic ≥ 10%] ), As Determined By An Fda-Approved Test, With No Egfr Or Alk Genomic Tumor Aberrations. ( 1.2 ) In Combination With Bevacizumab, Paclitaxel, And Carboplatin, For The First-Line Treatment Of Adult Patients With Metastatic Non-Squamous Nsclc With No Egfr Or Alk Genomic Tumor Aberrations. ( 1.2 ) In Combination With Paclitaxel Protein-Bound And Carboplatin For The First-Line Treatment Of Adult Patients With Metastatic Non-Squamous Nsclc With No Egfr Or Alk Genomic Tumor Aberrations ( 1.2 ) For The Treatment Of Adult Patients With Metastatic Nsclc Who Have Disease Progression During Or Following Platinum-Containing Chemotherapy. Patients With Egfr Or Alk Genomic Tumor Aberrations Should Have Disease Progression On Fda-Approved Therapy For Nsclc Harboring These Aberrations Prior To Receiving Tecentriq. ( 1.2 ) Triple-Negative Breast Cancer (Tnbc) In Combination With Paclitaxel Protein-Bound For The Treatment Of Adult Patients With Unresectable Locally Advanced Or Metastatic Tnbc Whose Tumors Express Pd-L1 (Pd-L1 Stained Tumor-Infiltrating Immune Cells [Ic] Of Any Intensity Covering ≥ 1% Of The Tumor Area), As Determined By An Fda Approved Test. This Indication Is Approved Under Accelerated Approval Based On Progression Free Survival. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial(S). ( 1.3 ) Small Cell Lung Cancer (Sclc) In Combination With Carboplatin And Etoposide, For The First-Line Treatment Of Adult Patients With Extensive-Stage Small Cell Lung Cancer (Es-Sclc). ( 1.4 ) Heptatocellular Carcinoma (Hcc) In Combination With Bevacizumab For The Treatment Of Patients With Unresectable Or Metastatic Hcc Who Have Not Received Prior Systemic Therapy ( 1.5 ) Melanoma In Combination With Cobimetinib And Vemurafenib For The Treatment Of Patients With Braf V600 Mutation-Positive Unresectable Or Metastatic Melanoma. ( 1.6 ) 1.1 Urothelial Carcinoma Tecentriq Is Indicated For The Treatment Of Adult Patients With Locally Advanced Or Metastatic Urothelial Carcinoma Who: Are Not Eligible For Cisplatin-Containing Chemotherapy And Whose Tumors Express Pd-L1 (Pd-L1 Stained Tumor-Infiltrating Immune Cells [Ic] Covering ≥ 5% Of The Tumor Area), As Determined By An Fda-Approved Test [See Dosage And Administration (2.1) ] , Or Are Not Eligible For Any Platinum-Containing Chemotherapy Regardless Of Pd-L1 Status, Or Have Disease Progression During Or Following Any Platinum-Containing Chemotherapy, Or Within 12 Months Of Neoadjuvant Or Adjuvant Chemotherapy This Indication Is Approved Under Accelerated Approval Based On Tumor Response Rate And Durability Of Response [See Clinical Studies (14.1) ] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial(S). 1.2 Non-Small Cell Lung Cancer Tecentriq, As A Single Agent, Is Indicated For The First-Line Treatment Of Adult Patients With Metastatic Non-Small Cell Lung Cancer (Nsclc) Whose Tumors Have High Pd-L1 Expression (Pd-L1 Stained ≥ 50% Of Tumor Cells [Tc ≥ 50%] Or Pd-L1 Stained Tumor-Infiltrating Immune Cells [Ic] Covering ≥ 10% Of The Tumor Area [Ic ≥ 10%]), As Determined By An Fda-Approved Test, With No Egfr Or Alk Genomic Tumor Aberrations. Tecentriq, In Combination With Bevacizumab, Paclitaxel, And Carboplatin, Is Indicated For The First-Line Treatment Of Adult Patients With Metastatic Non-Squamous Nsclc With No Egfr Or Alk Genomic Tumor Aberrations. Tecentriq, In Combination With Paclitaxel Protein-Bound And Carboplatin, Is Indicated For The First-Line Treatment Of Adult Patients With Metastatic Non-Squamous Nsclc With No Egfr Or Alk Genomic Tumor Aberrations. Tecentriq, As A Single-Agent, Is Indicated For The Treatment Of Adult Patients With Metastatic Nsclc Who Have Disease Progression During Or Following Platinum-Containing Chemotherapy. Patients With Egfr Or Alk Genomic Tumor Aberrations Should Have Disease Progression On Fda-Approved Therapy For Nsclc Harboring These Aberrations Prior To Receiving Tecentriq. 1.3 Locally Advanced Or Metastatic Triple-Negative Breast Cancer Tecentriq, In Combination With Paclitaxel Protein-Bound, Is Indicated For The Treatment Of Adult Patients With Unresectable Locally Advanced Or Metastatic Triple-Negative Breast Cancer (Tnbc) Whose Tumors Express Pd-L1 (Pd-L1 Stained Tumor-Infiltrating Immune Cells [Ic] Of Any Intensity Covering ≥ 1% Of The Tumor Area), As Determined By An Fda-Approved Test [See Dosage And Administration (2.1)] . This Indication Is Approved Under Accelerated Approval Based On Progression Free Survival [See Clinical Studies (14.3) ] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial(S). 1.4 Small Cell Lung Cancer Tecentriq, In Combination With Carboplatin And Etoposide, Is Indicated For The First-Line Treatment Of Adult Patients With Extensive-Stage Small Cell Lung Cancer (Es-Sclc). 1.5 Hepatocellular Carcinoma Tecentriq, In Combination With Bevacizumab, Is Indicated For The Treatment Of Patients With Unresectable Or Metastatic Hepatocellular Carcinoma (Hcc) Who Have Not Received Prior Systemic Therapy. 1.6 Melanoma Tecentriq, In Combination With Cobimetinib And Vemurafenib, Is Indicated For The Treatment Of Patients With Braf V600 Mutation-Positive Unresectable Or Metastatic Melanoma [See Dosage And Administration (2.1) ] .
|