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New Drugs Approved in October

Calquence
Calquence

The FDA gave accelerated approval to Calquence (acalabrutinib) on October 31, 2017 for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.

Developed by AstraZeneca Pharmaceuticals LP, Calquence is a kinase inhibitor that works by blocking an enzyme needed by the cancer to multiply and spread.

Mantle cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma. According to the National Cancer Institute at the National Institutes of Health, it represents 3 to 10 percent of all non-Hodgkin lymphoma cases in the U.S.

In clinical trials, 80% of patients receiving Calquence achieved an overall response, with 40% achieving a complete response.

Since the drug has now been granted accelerated approval, further study is required to verify and describe anticipated clinical benefits of Calquence, and AstraZeneca is currently conducting this trial.

AstraZeneca expects Calquence to reach potential peak-year sales in excess of $5 billion globally.