Difference between revisions of "Atezolizumab (Tecentriq)"

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==Diseases for which it is used==
 
==Diseases for which it is used==
 
*[[Bladder cancer]]
 
*[[Bladder cancer]]
 +
*[[Breast cancer, triple negative]]
 
*[[Non-small cell lung cancer]]
 
*[[Non-small cell lung cancer]]
  
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*4/17/2017: FDA granted accelerated approval for an expanded indication for patients with locally advanced or metastatic [[bladder cancer|urothelial carcinoma]] who are not eligible for [[Cisplatin (Platinol)|cisplatin-containing]] chemotherapy, or have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy.<ref name="insert"></ref> ''(No longer needs to be used after [[:Category:Platinum_agents|platinum-containing]] chemotherapy)''
 
*4/17/2017: FDA granted accelerated approval for an expanded indication for patients with locally advanced or metastatic [[bladder cancer|urothelial carcinoma]] who are not eligible for [[Cisplatin (Platinol)|cisplatin-containing]] chemotherapy, or have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy.<ref name="insert"></ref> ''(No longer needs to be used after [[:Category:Platinum_agents|platinum-containing]] chemotherapy)''
 
*6/19/2018: FDA label revised for the treatment of patients with locally advanced or metastatic [[bladder cancer|urothelial carcinoma]] who:
 
*6/19/2018: FDA label revised for the treatment of patients with locally advanced or metastatic [[bladder cancer|urothelial carcinoma]] who:
**Are not eligible for [[Cisplatin (Platinol)|cisplatin-containing]] therapy, 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 [[Cisplatin (Platinol)|cisplatin-containing]] therapy, and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering at least 5% of the tumor area), as determined by an FDA-approved test, or
 
**Are not eligible for any [[:Category:Platinum_agents|platinum-containing]] therapy regardless of PD-L1 status. ''(Conditional approval based on PD-L1 expression)''
 
**Are not eligible for any [[:Category:Platinum_agents|platinum-containing]] therapy regardless of PD-L1 status. ''(Conditional approval based on PD-L1 expression)''
 +
 +
===[[Breast cancer, triple negative]]===
 +
*3/8/2019: Granted accelerated approval in combination with [[Paclitaxel, nanoparticle albumin-bound (Abraxane)|paclitaxel protein-bound]] for adult patients with unresectable locally advanced or metastatic [[Breast cancer, triple negative|triple-negative breast cancer (TNBC)]] whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering at least 1% of the tumor area) ''(New disease entity)''
  
 
===[[Non-small cell lung cancer]]===
 
===[[Non-small cell lung cancer]]===
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[[Category:Bladder cancer medications]]
 
[[Category:Bladder cancer medications]]
 +
[[Category:Breast cancer medications]]
 
[[Category:Non-small cell lung cancer medications]]
 
[[Category:Non-small cell lung cancer medications]]
  
 
[[Category:FDA approved in 2016]]
 
[[Category:FDA approved in 2016]]

Revision as of 16:48, 9 March 2019

General information

Class/mechanism: PD-L1 antibody. Atezolizumab targets PD-L1 (programmed cell death-1 ligand 1) which is expressed on tumor cells and tumor-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on T-cells. By interfering with the binding of PD-L1 to T-cell receptors, it can cause upregulation of the anti-tumor immune response.[1][2][3][4][5]
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, Medscape, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

Bladder cancer

  • 5/18/2016: Granted FDA accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
    • Have disease progression during or following platinum-containing chemotherapy
    • Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
  • 4/17/2017: FDA granted accelerated approval for an expanded indication for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy, or have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy.[1] (No longer needs to be used after platinum-containing chemotherapy)
  • 6/19/2018: FDA label revised for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
    • Are not eligible for cisplatin-containing therapy, and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering at least 5% of the tumor area), as determined by an FDA-approved test, or
    • Are not eligible for any platinum-containing therapy regardless of PD-L1 status. (Conditional approval based on PD-L1 expression)

Breast cancer, triple negative

  • 3/8/2019: Granted accelerated approval in combination with paclitaxel protein-bound for 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 at least 1% of the tumor area) (New disease entity)

Non-small cell lung cancer

  • 10/18/2016: FDA approval expanded for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab. (New disease entity)
  • 12/6/2018: Approved in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations. (Approval extended to the first-line setting and restricted to non-squamous histology)

Also known as

  • Code names: MPDL3280A, RG7446
  • Brand name: Tecentriq

References

  1. 1.0 1.1 1.2 1.3 Atezolizumab (Tecentriq) package insert
  2. Atezolizumab (Tecentriq) package insert (locally hosted backup)
  3. Tecentriq manufacturer's website
  4. Naiyer A. Rizvi, Laura Quan Man Chow, Luc Yves Dirix, Scott N. Gettinger, Michael S. Gordon, Fairooz F. Kabbinavar, Joachim Von Pawel, Jean-Charles Soria, Colombe Chappey, Ahmad Mokatrin, Alan Sandler, Daniel Waterkamp, David R. Spigel. Clinical trials of MPDL3280A (anti-PDL1) in patients (pts) with non-small cell lung cancer (NSCLC). 2014 ASCO Annual Meeting abstract TPS8123. link to abstract
  5. Pivotal Phase II study showed Roche's investigational immunotherapy atezolizumab shrank tumours in people with a specific type of lung cancer Roche.com, 8/17/2015.
  6. Atezolizumab (Tecentriq) patient drug information (UpToDate)