Imfinzi, a PD-L1 inhibitor manufactured by AstraZeneca (NASDAQ:AZN), along with chemotherapy, has been granted approval by the Food and Drug Administration (FDA) for the treatment of locally progressed or metastatic biliary tract cancer (BTC).
The permission was granted based on the findings of the TOPAZ-1 phase III research, which demonstrated that the combination of Imfinzi and chemotherapy led to a 20% reduction in the risk of death compared to the risk of death caused by chemotherapy alone.
It is the first immunotherapy regimen approved for this group of uncommon and aggressive tumors that develop in the bile ducts and gallbladder. The combination of imfinzi and chemotherapy, which consists of gemcitabine and cisplatin, received approval. Patients diagnosed with BTC have generally been given a dismal prognosis, which has generated a need for therapeutic alternatives that are more effective. A novel treatment option that meaningfully enhances life expectancy has been made available thanks to the approval of Imfinzi in combination with chemotherapy.
Shares of AstraZeneca (NASDAQ:AZN) have increased by 4.2% so far this year, in contrast to a loss of 4.8% for the industry as a whole.
Imfinzi is now authorized to treat unresectable stage III non-small-cell lung cancer (NSCLC) and the initial treatment of extensive stage small cell lung carcinoma (ES-SCLC). Imfinzi is also being evaluated for multiple cancers, either alone or in combination with other regimens, including phase III studies in earlier settings in non-small cell lung cancer and small cell lung cancer, bladder cancer, several gastrointestinal cancers, ovarian cancer, endometrial cancer, and other solid tumors. Imfinzi could be used to treat these cancers independently or in conjunction with other treatments. Regulatory applications submitted to the FDA requesting approval of Imfinzi in combination with tremelimumab for the treatment of advanced hepatocellular carcinoma (HCC, often known as liver cancer) are currently undergoing priority assessment, and a decision is anticipated to be made this year.
In the first half of 2022, the drug reported sales of $1.29 billion, representing a 16% increase compared to the previous year’s first-half totals. The acceptance of a broader range of applications for BTC is likely to have a positive impact on sales in subsequent quarters.
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