Durvalumab

Therapeutic indications

Durvalumab is indicated for:

Locally advanced non-small cell lung cancer with PD-L1 ≥1%

Population group: only adults (18 years old or older)

Durvalumab as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

10 mg/kg once every 2 weeks

Metastatic non-small cell lung cancer, with no EGFR or ALK positive mutations

Population group: only adults (18 years old or older)

Durvalumab in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

During platinum chemotherapy 1,500 mg every 3 weeks for 4 cycles and post-platinum chemotherapy 1,500 mg every 4 weeks

Monotherapy of advanced or unresectable hepatocellular carcinoma

Population group: only adults (18 years old or older)

Durvalumab as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

For this indication, competent medicine agencies globally authorize below treatments (click for details):

1,500 mg every 4 weeks

Combination therapy of advanced or unresectable hepatocellular carcinoma

Population group: only adults (18 years old or older)

Durvalumab in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

For this indication, competent medicine agencies globally authorize below treatments (click for details):

1,500 mg administered in combination with 300 mg tremelimumab as a single dose at Cycle 1/Day 1, followed by 1,500 mg as monotherapy every 4 weeks

Extensive-stage small cell lung cancer (ES-SCLC)

Population group: only adults (18 years old or older)

Durvalumab in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

For this indication, competent medicine agencies globally authorize below treatments (click for details):

1,500 mg in combination with chemotherapy every 3 weeks for 4 cycles, followed by 1,500 mg every 4 weeks as monotherapy

Biliary tract cancer (BTC)

Population group: only adults (18 years old or older)

Durvalumab in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with unresectable or metastatic biliary tract cancer (BTC).

For this indication, competent medicine agencies globally authorize below treatments (click for details):

1,500 mg in combination with chemotherapy every 3 weeks up to 8 cycles, followed by 1,500 mg every 4 weeks as monotherapy

Endometrial cancer

Population group: only adults (18 years old or older)

Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with:

durvalumab as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)
durvalumab in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).

For this indication, competent medicine agencies globally authorize below treatments (click for details):

1,120 mg every 3 weeks for 4-6 cycles, followed by 1,500 mg every 4 weeks

Resectable non-small cell lung cancer at high risk of recurrence, with no EGFR or ALK positive mutations

Population group: only adults (18 years old or older)

Durvalumab in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by durvalumab as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

1 500 mg every 3 weeks for up to 4 cycles prior to surgery, followed by 1 500 mg every 4 weeks for up to 12 cycles after surgery

Monotherapy of limited-stage small cell lung cancer (LS-SCLC)

Population group: only adults (18 years old or older)

Durvalumab as monotherapy is indicated for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

1,500 mg every 4 weeks

Muscle invasive bladder cancer (MIBC)

Population group: only adults (18 years old or older)

Durvalumab in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by durvalumab as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).

For this indication, competent medicine agencies globally authorize below treatments (click for details):

1,500 mg every 3 weeks for 4 cycles prior to surgery, followed by 1,500 mg every 4 weeks as for up to 8 cycles after surgery

Contraindications

Durvalumab is contraindicated in the following cases:

Pregnancy

Pregnancy

Lactation

Lactation

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