INDICATIONS AND USAGE（适应症）

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, or

are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

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

TECENTRIQ, as a single-agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II to IIIA [see Clinical Studies (14.2)] non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.

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.

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).

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.

Melanoma

TECENTRIQ, in combination with cobimetinib and vemurafenib, is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

DOSAGE（服用剂量）

The recommended dosages of TECENTRIQ administered intravenously as a single agent are presented as follows:

840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks for Urothelial Carcinoma/Metastatic NSCLC

840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks for Adjuvant Treatment of NSCLC

The recommended intravenous dosages of TECENTRIQ in combination with other therapeutic agents are presented as follows:

840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks for NSCLC. Administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day. 

840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks for SCLC. Administer TECENTRIQ prior to chemotherapy when given on the same day.

840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks for HCC. Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks.

840 mg every 2 weeks or 1200 mg every 3 weeks or 1680 mg every 4 weeks for Melanoma. Administer TECENTRIQ with cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 720 mg orally twice daily.

Prior to initiating TECENTRIQ, patients should receive a 28 day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28.

ADVERSE REACTIONS（不良反应）

The common side effects of TECENTRIQ when used alone include:

feeling tired or weak

decreased appetite

nausea

cough

shortness of breath

The most common side effects of TECENTRIQ when used in lung cancer with other anti-cancer medicines include:

feeling tired or weak

nausea

hair loss

constipation

diarrhea

decreased appetite

The most common side effects of TECENTRIQ when used in hepatocellular carcinoma with bevacizumab include:

high blood pressure

feeling tired or weak

too much protein in the urine

The most common side effects of TECENTRIQ when used in melanoma with cobimetinib and vemurafenib include:

skin rash

joint, muscle, or bone pain

feeling tired or weak

liver injury

fever

nausea

itching

swelling of legs or arms

mouth swelling (sometimes with sores)

low thyroid hormone levels

sunburn or sun sensitivity

TECENTRIQ may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of TECENTRIQ.

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/6fa682c9-a312-4932-9831-f286908660ee/spl-doc?hl=tecentriq

Tecentriqinformation