FLASCO

Recent update to the TECENTRIQ (atezolizumab) Prescribing Information

  • Katrina Williams
  • July 2, 2019

There was a recent update to the TECENTRIQ (atezolizumab) Prescribing Information that impacted the dosing regimens for certain indications. This change would allow for either the 840 mg or 1200 mg vials to be used for those indications. Please see below for the NDC information.

Updated Prescribing Information

  • Urothelial Carcinoma

o   Administer TECENTRIQ as:

  • 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks
  • First Line NSCLC

o   When administering in combination with bevacizumab and paclitaxel and carboplatin, administer TECENTRIQ 1200 mg every 3 weeks prior to chemotherapy or other antineoplastic drugs.

o   Following completion of 4-6 cycles of paclitaxel and carboplatin, and if bevacizumab is discontinued, administer TECENTRIQ as:

  • 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks
  • Second Line NSCLC

o   Administer TECENTRIQ as a single agent as:

  • 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks
  • Small Cell Lung Cancer

o   When administering with carboplatin and etoposide, administer TECENTRIQ 1200 mg every 3 weeks prior to chemotherapy.

o   Following completion of 4 cycles of carboplatin and etoposide, administer TECENTRIQ as:

  • 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks

Please see below for NDC information for the 1200 and 840 mg vials of TECENTRIQ:

  • 840 mg/14 mL single-dose vial

o   50242-918-01 (on packaging)

o   50242-0918-01 (used for billing)

  • 1200 mg/20 mL single-dose vial

o   50242-917-01 (on packaging)

o   50242-0917-01 (used for billing)

Indication Statements

Metastatic Urothelial Carcinoma (mUC)

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, 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Non-Small Cell Lung Cancer (NCSLC)

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 (nsqNSCLC) with no EGFR or ALK genomic tumor aberrations.

TECENTRIQ, as a single-agent, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (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.

Small Cell Lung Cancer (SCLC)

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).

https://www.gene.com/download/pdf/tecentriq_prescribing.pdf.

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