UK-based AstraZeneca PLC (GB:AZN) announced that its drug Calquence has won the U.S. FDA approval for treating mantle cell lymphoma (MCL). The company believes that this approval strengthens its confidence in Calquence as a key therapy for various blood cancers. Notably, MCL is a rare type of blood cancer that affects white blood cells of the lymph nodes and is often detected in advanced stages. Following the announcement, AZN stock gained over 1% as of writing.
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AstraZeneca is a leading global pharmaceutical company, serving billions of people worldwide. The company operates in three main categories: Oncology, Rare Diseases, and BioPharmaceuticals.
FDA Approves Calquence to Treat Untreated MCL
According to the company’s update, the U.S. regulator, FDA (Food and Drug Administration) has given the green light for Calquence (acalabrutinib) to be used in combination with bendamustine and rituximab. This is applicable for the treatment of adults with previously untreated MCL who cannot undergo a stem cell transplant.
The latest approval is based on the Calquence ECHO Phase III trial, which demonstrated over 16 months of improved progression-free survival compared to chemoimmunotherapy alone.
In May 2024, AstraZeneca announced its ambition to reach $80 billion in sales by 2030, with a strong focus on expanding its cancer drug portfolio to drive growth. The company is dedicated to tackling some of the most difficult-to-treat cancers. Through continuous innovation, it has developed one of the industry’s most diverse portfolios and pipelines.
In December, AstraZeneca received FDA approval for Imfinzi, making it the first immunotherapy available for limited-stage small cell lung cancer.
Is AstraZeneca Share a Good Buy?
As per the consensus rating on TipRanks, AZN stock received a Moderate Buy rating, supported by a total of 13 recommendations. It includes eight Buy and five Hold ratings from analysts. The AstraZeneca share price forecast stands at 13,725.8.1p, which is 25.2% above the current trading level.
