New FDA Approval for IMFINZI® (durvalumab)
On September 9th, 2022
The US Food and Drug Administration (FDA) has approved a new indication for IMFINZI® (durvalumab), in combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).1
BTCs comprise a heterogeneous group of rare cancers, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, that account for approximately 1% of all new cancer cases annually in the United States.2-5 The majority of BTCs (about 60% to 70%) are diagnosed as unresectable or metastatic disease,6 and more than 10 years have passed since gemcitabine plus cisplatin (gem-cis) was established as the standard of care in the first-line systemic treatment of advanced BTCs.7,8
IMFINZI, in combination with gem-cis, was studied in 685 patients with locally advanced or metastatic BTCs in the Phase III, randomized, double-blind, placebo-controlled, multicenter, global TOPAZ-1 trial, results of which were published in the June 2022 issue of NEJM Evidence.9 In this trial, IMFINZI + gem-cis demonstrated significant improvement in the primary endpoint of overall survival (OS) vs gem-cis + placebo1,9:
- 20% lower risk of death vs gem-cis + placebo (HR=0.80 [95% CI: 0.66-0.97]; P=0.021)*
- Median OS: 12.8 months (95% CI: 11.1-14) with IMFINZI + gem-cis vs 11.5 months (95% CI: 10.1-12.5) with gem-cis + placebo
- 24-month OS: 24.9% (95% CI: 17.9-32.5) with IMFINZI + gem-cis and 10.4% (95% CI: 4.7-18.8) with gem-cis + placebo
- OS at 12, 18, and 24 months were descriptive endpoints and were not formally tested for statistical significance
Serious adverse reactions occurred in 47% of patients receiving IMFINZI + gem-cis. The most frequent (≥2% of patients) were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%), and acute kidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI + gem-cis and included ischemic or hemorrhagic stroke (reported in 4 patients), sepsis, and upper gastrointestinal hemorrhage (reported in 2 patients each).1
Based on these results, the FDA granted IMFINZI, in combination with gem-cis, priority review status in May 2022 and full approval on September 2, 2022 —making it the first [and only] FDA-approved regimen for the first-line treatment of patients with locally advanced or metastatic BTCs.1,10,11
Additionally, the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hepatobiliary Cancers recommend durvalumab (IMFINZI®) in combination with gemcitabine + cisplatin as a Category 1, preferred systemic therapy option for primary treatment of patients with unresectable or metastatic BTCs.12†
INDICATIONS
- IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
- IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
- IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Please see complete Prescribing Information including Medication Guide.
You may report side effects related to AstraZeneca products by clicking here.
The US Food and Drug Administration (FDA) has approved a new indication for IMFINZI® (durvalumab), in combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).1
BTCs comprise a heterogeneous group of rare cancers, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, that account for approximately 1% of all new cancer cases annually in the United States.2-5 The majority of BTCs (about 60% to 70%) are diagnosed as unresectable or metastatic disease,6 and more than 10 years have passed since gemcitabine plus cisplatin (gem-cis) was established as the standard of care in the first-line systemic treatment of advanced BTCs.7,8
IMFINZI, in combination with gem-cis, was studied in 685 patients with locally advanced or metastatic BTCs in the Phase III, randomized, double-blind, placebo-controlled, multicenter, global TOPAZ-1 trial, results of which were published in the June 2022 issue of NEJM Evidence.9 In this trial, IMFINZI + gem-cis demonstrated significant improvement in the primary endpoint of overall survival (OS) vs gem-cis + placebo1,9:
- 20% lower risk of death vs gem-cis + placebo (HR=0.80 [95% CI: 0.66-0.97]; P=0.021)*
- Median OS: 12.8 months (95% CI: 11.1-14) with IMFINZI + gem-cis vs 11.5 months (95% CI: 10.1-12.5) with gem-cis + placebo
- 24-month OS: 24.9% (95% CI: 17.9-32.5) with IMFINZI + gem-cis and 10.4% (95% CI: 4.7-18.8) with gem-cis + placebo
- OS at 12, 18, and 24 months were descriptive endpoints and were not formally tested for statistical significance
Serious adverse reactions occurred in 47% of patients receiving IMFINZI + gem-cis. The most frequent (≥2% of patients) were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%), and acute kidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI + gem-cis and included ischemic or hemorrhagic stroke (reported in 4 patients), sepsis, and upper gastrointestinal hemorrhage (reported in 2 patients each).1
Based on these results, the FDA granted IMFINZI, in combination with gem-cis, priority review status in May 2022 and full approval on September 2, 2022 —making it the first [and only] FDA-approved regimen for the first-line treatment of patients with locally advanced or metastatic BTCs.1,10,11
Additionally, the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hepatobiliary Cancers recommend durvalumab (IMFINZI®) in combination with gemcitabine + cisplatin as a Category 1, preferred systemic therapy option for primary treatment of patients with unresectable or metastatic BTCs.12†
INDICATIONS
- IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
- IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
- IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Please see complete Prescribing Information including Medication Guide.
You may report side effects related to AstraZeneca products by clicking here.
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