×××ר××
×צפ××× ×××××¢ ××ר×× ×ר×פ××× ×ש
××××× ×¡ ××ש××× ×. ×× ××× × ×¨×©×× ××× ×¡ ×
×רש×× ×ר×פ××× ××× ×©× ×קצ××¢×ת רפ×××××.
× ×ª×× × ×ª×¨×פ×
××רש×

| ××× ×× ×× × ×ספ××
|
|
| ×§×××¦× ×¤×¨××§×××××ת (ATC4)
|
L01FF PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors
|
| ×ר××× ×¤×¢×× (ATC5)
|
Â
|
| צ×רת ×ת×
|
ת××-×ר××× - I.V
|
| צ×רת ××× ××
|
תר××× ×××× ×ª ת×××¡× ×××× ×¤××××, CONCENTRATE FOR SOLUTION FOR INFUSION ××× ×עת ××× ×× ×תר ×× ×רע×× ×ש ××××× ×ת ×תר××¤× ××ת×× ×××× ×× ××××××¥ ××¤× ×©××פ××¢ ××¢××× ×צר××
|
| ×ת××××
|
Urothelial Carcinoma⢠TECENTRIQ (atezolizumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumours have a PD-L1 expression ⥠5%.⢠TECENTRIQ is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy.- Non-Small Cell Lung Cancer â¢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 approved test, with no EGFR or ALK genomic tumor aberrations.â¢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, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC). In patients with EGFR mutant or ALK-positive NSCLC, TECENTRIQ, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated only after failure of appropriate targeted therapies.⢠TECENTRIQ is indicated for the treatment of patients with metastatic NSCLC who are naïve to anti-PD-L1 or anti-PD-1 therapies and have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ.- Locally Advanced or Metastatic Triple-Negative Breast Cancer Tecentriq, in combination with nab-paclitaxel, is indicated for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors have PD-L1 expression â¥1% and who have not received prior chemotherapy for metastatic disease.- Small Cell Lung CancerTECENTRIQ, 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)."Hepatocellular CarcinomaTECENTRIQ, 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.MelanomaTECENTRIQ, in combination with cobimetinib and vemurafenib, is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
|
| × ×ª×× × ×ס×
|
ת×ר×× ××××× ×ס×
- 12/01/2017
|
×××××ת ×ס×
- תר××¤× ×××××ת ×ר×ש×× ×¢'× ×¨××¤× ××××× ×× ××××× ××רת
|
×ת×××× ×ס×
| ×ת×××× |
ת×ר×× ××××× |
ת××× ×§××× × |
Class Effect |
××¦× ×××× |
×ס×ס ×××××ת
|
| ×תר××¤× ×ª×× ×ª× ×××× ×תרפ×× ×××פ×× ×סר×× ×תק×× ××§××× ×× ×ר××¨×ª× ×©× ×ר×× ××©×ª× ××××× ××¢×× × ×¢× ××× ××××: 1. ×§××× ××פ×× ×××××ª×¨×¤× ×§××× ××ש×ר ש××× ×ª×¨×××ת פ×××× ×× ×××××ª× ××ר×רת×ת; 2. ××××ª× ×תק××× ×ת×× 12 ×××ש×× ×××פ×× ×××××ª×¨×¤× ××ש×ר ש××× ×ª×¨×××ת פ×××× ×× ××ס×רת ×ש×××× (adjuvant) ×× noeoadjuvant. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
|
12/01/2017 |
××× ×§×××××× |
|
Urothelial cancer |
|
| ×××× ×תרפ×× ×סר×× ×¨××× ×ר××¨×ª× ×ס×× Non small cell lung cancer (NSCLC) ×××××× ×©××××ª× ×תק××× ×××ר ×§× ××פ×× ×××××ª×¨×¤× ×§××× ×××סס פ×××× ××. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
|
12/01/2018 |
××× ×§×××××× |
|
NSCLC, non small cell lung cancer |
|
| ×ש×××× ×¢× ××××תרפ×× ××××× ×¡×¨×× ×©× ×תק×× ××§××× ×× × ×ª×× ×× ×ר××¨×ª× ×ס×× triple negative (TNBC) ××××× PDL1 ××¢×¨× ×©× 1% ×××¢××, ×שר ××¨× ×§××× ××פ×× ×××××ª×¨×¤× ×××××ª× ××תק××ת ×× ××ר×רת×ת. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors.
|
30/01/2020 |
××× ×§×××××× |
|
TNBC, Triple negative breast cancer |
|
| ××× ×תרפ×× ×סר×× ×תק×× ××§××× ×× ×ר××¨×ª× ×©× ×ר×× ××©×ª× ××§× ××פ×× ×¨×ש×× ××××× ××¢×× × ×¢× ××× ××××: ×. ××× × ×ת××× ×××פ×× ××ש×× ×××××ª×¨×¤× ××××× Cisplatin ××××× PDL1 ××¤× PD-L1 stained tumor infiltrating cells [IC] covering > 5%. ××¢× ××× ×× ×××× ×©××× × ×ת××× ×××פ×× ××ש×× ×××××ª×¨×¤× ××××× Cisplatin ××××ר ××¢×× × ×¢× ××× ××××: 1. ס×××ס תפק××× ××¤× WHO ×× ECOG ××¢× 2 ×× ××¤× Karnofsky performance status ××¢×¨× ××× 60% ×-70%. 2. פ×× ×× ×§×¨×××× ×× (× ××× ×× ×××ש×) × ××× ×-60 ×"×/××§× 3. ××××× ×©×××¢× ×××××××ר×× ××¢×¨× ×××× ×-2 ××¤× CTCAE; 4. × ××ר×פת×× ×¤×¨×פר××××ת ××¢×¨× ×××× ×-2 ××¤× CTCAE; 5. ×× ×¡×¤××§× ××××ת ××ר×× III ××¤× ×-NYHA. ×. ××× × ×ת××× ×××פ×× ××ש×× ××××תרפ×× ××××× ×ª×¨×××ת פ×××× ×× ××ש××, ××× ×ª××ת ×ר×ת ××××× PDL1. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors.
|
30/01/2020 |
××× ×§×××××× |
|
Urothelial cancer |
|
| ×ש×××× ×¢× ××××תרפ×× ×-Bevacizumab ××§× ××פ×× ×¨×ש×× ×סר×× ×¨××× ×ר××¨×ª× ×ס×× NSCLC ×××××× ×¢× ×¨××ת ××××× PDL1 ×ר×× × ×××× ×-50% (×××× ××××× ×©××× × ×××××× PDL1), ש××× × ×××××× ×××צ××ת ×ס×× EGFR, ALK, ROS1. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors.
|
30/01/2021 |
××× ×§×××××× |
|
NSCLC, non small cell lung cancer |
|
| ×××× ×תרפ×× ×× ×ש×××× ×¢× ××××תרפ×× ×-Bevacizumab ××§× ××פ×× ×¨×ש×× ×סר×× ×¨××× ×ר××¨×ª× ×ס×× NSCLC ×××××× ××××××× ××××× PDL1 ×ר×× ×©× 50% ×××¢××, ש××× × ×××××× ×××צ××ת ×ס×× EGFR, ALK, ROS1. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors.
|
30/01/2021 |
××× ×§×××××× |
|
NSCLC, non small cell lung cancer |
|
| ×ש×××× ×¢× Bevacizumab, ×××פ×× ×סר×× ×פ××צ×××××¨× ×× × ×ª×× ×× ×ר×רת×, ×××××× ×©××¨× ×§×××× ××פ×× ×¡×ס××× ××××ת×. ××××× ××××ª× ×××× ××××× ×××× ×××ת ××תר×פ×ת ××××ת â Atezolizumab + Bevacizumab, Lenvatinib, Sorafenib. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors.
|
01/03/2021 |
××× ×§×××××× |
|
Hepatocellular carcinoma |
|
| ×××× ×תרפ×× ×××פ×× ×סר×× ×תק×× ××§××× ×× ×ר××¨×ª× ×©× ×ר×× ××©×ª× ××××× ××¢×× × ×¢× ××× ××××: ×. ××××ª× ×תק××× ×××ר שק××× ××פ×× ×××××ª×¨×¤× ×§××× ××ש×ר ש××× ×ª×¨×××ת פ×××× ×× ×××××ª× ××ר×רת×ת; ×. ××××ª× ×תק××× ×ת×× 12 ×××ש×× ×××פ×× ×××××ª×¨×¤× ××ש×ר ש××× ×ª×¨×××ת פ×××× ×× ××ס×רת ×ש×××× (adjuvant) ×× noeoadjuvant. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors.
|
03/02/2022 |
××× ×§×××××× |
|
Urothelial cancer |
|
| ××× ×תרפ×× ×××פ×× ×ש××× ×××ר × ×ת×× ×××פ×× ×××××ª×¨×¤× ×××סס פ×××× ××, ×סר×× ×¨××× ×ס×× NSCLC ש××× ×××× II ×¢× IIIa, ××××× PDL1 ×ר×× ×©× 50% ×××¢×× ×ת×× ××××××, ×ש××× × ×××× ×××צ××ת ×ס×× EGFR ×× ALK. ××©× ×××פ×× ×ת×ש×ר ××ת×××× ×× ×× ××¢×× ×¢× ×©× ×. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors. ×ש×× ×××× × ×ª×× ×××× ××××× ×××× ×××פ×× ×ר×× × ×ת××× ×-Nivolumab ×× ×××פ×× ×ש××× ×××ר × ×ת×× ×-Atezolizumab. ××¢× ××× ×× ×¡×¨×× ×¨××× ×ש×× ×תק×× (×× × ×ª×× ×× ×ר×רת×) ×× ××××ר ××××ª× ×××× ××× ×¡×¨×× ×¨××× ×ש×× ×ר ××¡×¨× ×× ×ת××.
|
01/02/2023 |
××× ×§×××××× |
|
NSCLC, non small cell lung cancer |
|
| ××× ×תרפ×× ×××פ×× ×ש××× ×××ר × ×ת×× ×××פ×× ×××××ª×¨×¤× ×××סס פ×××× ××, ×סר×× ×¨××× ×ס×× NSCLC ש××× ×××× II ×¢× IIIa, ××××× PDL1 ×ר×× ×©× 50% ×××¢×× ×ת×× ××××××, ×ש××× × ×××× ×××צ××ת ×ס×× EGFR ×× ALK. ××©× ×××פ×× ×ת×ש×ר ××ת×××× ×× ×× ××¢×× ×¢× ×©× ×. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors. ×ש×× ×××× × ×ª×× ×××× ××××× ×××× ×××פ×× ×ר×× × ×ת××× ×-Nivolumab ×× ×××פ×× ×ש××× ×××ר × ×ת×× ×-Atezolizumab ×× Pembrolizumab. ××¢× ××× ×× ×¡×¨×× ×¨××× ×ש×× ×תק×× (×× × ×ª×× ×× ×ר×רת×) ×× ××××ר ××××ª× ×××× ××× ×¡×¨×× ×¨××× ×ש×× ×ר ××¡×¨× ×× ×ת××.
|
17/03/2024 |
××× ×§×××××× |
|
×סר×× ×¨××× ×ס×× NSCLC ש××× ×××× II ×¢× IIIa |
|
| ×××× ×תרפ××, ×××פ×× ×××××ר×× ××××××× ×× × ×©× ×ª××× ×××¢×× ×¢× ×¡×¨×§××× ×ס×× Alveolar soft part sarcoma (ASPS) ×× × ×ª××× ×× ×ר×רת×ת.
|
17/03/2024 |
××× ×§×××××× |
|
סרק××× ×ס×× Alveolar soft part sarcoma (ASPS) |
|
| ×ש×××× ×¢× Bevacizumab, ×××פ×× ×סר×× ×פ××צ×××××¨× ×× × ×ª×× ×× ×ר×רת×, ×××××× ×©××¨× ×§×××× ××פ×× ×¡×ס××× ××××ת×. ××××× ××××ª× ×××× ××××× ×××× ×××ת ××תר×פ×ת ××××ת â Atezolizumab + Bevacizumab, Lenvatinib, Sorafenib, Durvalumab + Tremelimumab. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors.
|
17/03/2024 |
××× ×§×××××× |
|
×××פ×× ×סר×× ×פ××צ×××××¨× ×× × ×ª×× ×× ×ר××¨×ª× |
|
|
| ש×××ש ×ס×
|
×ס×רת ××××× ×ס×
- ×תר××¤× ×ª×× ×ª× ×××פ×× ××קר×× ××××:
- ×××× ×תרפ×× ×××פ×× ×סר×× ×תק×× ××§××× ×× ×ר××¨×ª× ×©× ×ר×× ××©×ª× ××××× ××¢×× × ×¢× ××× ××××:
- ××××ª× ×תק××× ×××ר שק××× ××פ×× ×××××ª×¨×¤× ×§××× ××ש×ר ש××× ×ª×¨×××ת פ×××× ×× ×××××ª× ××ר×רת×ת;
- ××××ª× ×תק××× ×ת×× 12 ×××ש×× ×××פ×× ×××××ª×¨×¤× ××ש×ר ש××× ×ª×¨×××ת פ×××× ×× ××ס×רת ×ש×××× (adjuvant) ×× noeoadjuvant.
××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
- ××× ×תרפ×× ×סר×× ×תק×× ××§××× ×× ×ר××¨×ª× ×©× ×ר×× ××©×ª× ××§× ××פ×× ×¨×ש×× ××××× ××¢×× × ×¢× ××× ××××:
- ××× × ×ת××× ×××פ×× ××ש×× ×××××ª×¨×¤× ××××× Cisplatin ××××× PDL1 ××¤× PD-L1 stained tumor infiltrating cells [IC] covering > 5 ××××××
××¢× ××× ×× ×××× ×©××× × ×ת××× ×××פ×× ××ש×× ×××××ª×¨×¤× ××××× Cisplatin ××××ר ××¢×× × ×¢× ××× ××××:
- ס×××ס תפק××× ××¤× WHO ×× ECOG ××¢× 2 ×× ××¤× Karnofsky performance status ××¢×¨× ××× 60 ×××××× ×-70 ××××××
- פ×× ×× ×§×¨×××× ×× (× ××× ×× ×××ש×) × ××× ×-60 ×××××××ר/××§×
- ××××× ×©×××¢× ×××××××ר×× ××¢×¨× ×××× ×-2 ××¤× CTCAE
- × ××ר×פת×× ×¤×¨×פר×ת ××¢×¨× ×××× ×-2 ××¤× CTCAE
- ×× ×¡×¤××§× ××××ת ××ר×× III ××¤× ×-NYHA
- ××× × ×ת××× ×××פ×× ××ש×× ××××תרפ×× ××××× ×ª×¨×××ת פ×××× ×× ××ש××, ××× ×ª××ת ×ר×ת ××××× PDL1.
××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
- ××× ×תרפ×× ×××פ×× ×ש××× ×××ר × ×ת×× ×××פ×× ×××××ª×¨×¤× ×××סס פ×××× ××, ×סר×× ×¨××× ×ס×× NSCLC ש××× ×××× II ×¢× IIIa, ××××× PDL1 ×ר×× ×©× 50 ×××××× ×××¢×× ×ת×× ××××××, ×ש××× × ×××× ×××צ××ת ×ס×× EGFR ×× ALK.
××©× ×××פ×× ×ת×ש×ר ××ת×××× ×× ×× ××¢×× ×¢× ×©× ×. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors. ×ש×× ×××× × ×ª×× ×××× ××××× ×××× ×××פ×× ×ר×× × ×ת××× ×-Nivolumab ×× ×××פ×× ×ש××× ×××ר × ×ת×× ×-Atezolizumab ×× Pembrolizumab. ××¢× ××× ×× ×¡×¨×× ×¨××× ×ש×× ×תק×× (×× × ×ª×× ×× ×ר×רת×) ×× ××××ר ××××ª× ×××× ××× ×¡×¨×× ×¨××× ×ש×× ×ר ××¡×¨× ×× ×ת××
- ×××× ×תרפ×× ×סר×× ×¨××× ×ר××¨×ª× ×ס×× (Non small cell lung cancer (NSCLC ×××××× ×©××××ª× ×תק××× ×××ר ×§× ××פ×× ×××××ª×¨×¤× ×§××× ×××סס פ×××× ××.
××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
- ×××× ×תרפ×× ×× ×ש×××× ×¢× ××××תרפ×× ×-Bevacizumab ××§× ××פ×× ×¨×ש×× ×סר×× ×¨××× ×ר××¨×ª× ×ס×× NSCLC ×××××× ××××××× ××××× PDL1 ×ר×× ×©× 50 ×××××× ×××¢××, ש××× × ×××××× ×××צ××ת ×ס×× EGFR, ALK, ROS1.
××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
- ×ש×××× ×¢× ××××תרפ×× ×-Bevacizumab ××§× ××פ×× ×¨×ש×× ×סר×× ×¨××× ×ר××¨×ª× ×ס×× NSCLC ×××××× ×¢× ×¨××ת ××××× PDL1 ×ר×× × ×××× ×-50 ×××××× (×××× ××××× ×©××× × ×××××× PDL1), ש××× × ×××××× ×××צ××ת ×ס×× EGFR, ALK, ROS1.
××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
- ×ש×××× ×¢× ××××תרפ×× ××××× ×¡×¨×× ×©× ×תק×× ××§××× ×× × ×ª×× ×× ×ר××¨×ª× ×ס×× (triple negative (TNBC ××××× PDL1 ××¢×¨× ×©× 1 ×××××× ×××¢××, ×שר ××¨× ×§××× ××פ×× ×××××ª×¨×¤× ×××××ª× ××תק××ת ×× ××ר×רת×ת.
××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
- ×ש×××× ×¢× Bevacizumab, ×××פ×× ×סר×× ×פ××צ×××××¨× ×× × ×ª×× ×× ×ר×רת×, ×××××× ×©××¨× ×§×××× ××פ×× ×¡×ס××× ××××ת×.
××××× ××××ª× ×××× ××××× ×××× ×××ת ××תר×פ×ת ××××ת - Atezolizumab + Bevacizumab, Lenvatinib, Sorafenib, Durvalumab + Tremelimumab. ××××× ××××ª× ×××× ××××× ×××× ×תר××¤× ××ת ×××× ×תר×פ×ת ××שת××××ת ××שפ×ת ×-Checkpoint inhibitors
- ×××× ×תרפ××, ×××פ×× ×××××ר×× ××××××× ×× × ×©× ×ª××× ×××¢×× ×¢× ×¡×¨×§××× ×ס×× (Alveolar soft part sarcoma (ASPS ×× × ×ª××× ×× ×ר×רת×ת
- ××ª× ×תר××¤× ×××××¨× ×××¢×©× ××¤× ××¨×©× ×©× ×¨××¤× ××××× ×××× ×§×××××× ×× ×¨××¤× ××××× ×××ר×××××× ××××¤× ×××ר×××××× ××× ×§×××××ת.
|
|
| ×¢××× ×ר××¤× ××××ר×ת ××¢×××
|
Â
Â
|
ת××× ×ª ×ר×××
ת×ר×× ×¢××××: 10/08/2021
HOFFMANN
×××¡× ×ר××§ - Tecentriq
true
השינוי האחרון נעשה בֹ־17 ביוני 2025 ב־11:07