AstraZeneca ( AZN Quick Quote AZN - Free Report) announced that the FDA has approved its PD-L1 inhibitor, Imfinzi plus chemotherapy for treating locally advanced or metastatic biliary tract cancer (BTC).
The approval was based on data from the TOPAZ-1 phase III study, which showed that Imfinzi plus chemotherapy led to a 20% reduction in the risk of death versus chemotherapy alone.
Imfinzi plus chemotherapy (gemcitabine plus cisplatin) becomes the first immunotherapy regimen to be approved for this group of rare and aggressive cancers that occur in the bile ducts and gallbladder. Patients with BTC have historically faced a poor prognosis, creating the need for more effective treatment options. The approval of Imfinzi plus chemo offers a new treatment option that meaningfully extends survival.
This year so far, AstraZeneca’s shares have risen 4.2% against a decrease of 4.8% for the
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Imfinzi is presently approved for unresectable, stage III non-small-cell lung cancer (NSCLC) and first-line treatment of extensive-stage small cell lung cancer (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 NSCLC and SCLC, bladder cancer, several GI cancers, ovarian cancer, endometrial cancer, and other solid tumors. Regulatory applications seeking approval for Imfinzi in combination with tremelimumab in advanced hepatocellular carcinoma (HCC, liver cancer) are under priority review with the FDA, with a decision expected this year.
Imfinzi recorded sales of $1.29 billion in the first half of 2022, up 16% at a constant exchange rate. The approval for expanded use in BTC should further boost sales in future quarters.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see
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Some better-ranked stocks in the same sector are
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