FDA Approves Calquence (Acalabrutinib) for Mantle Cell Lymphoma

Written By:Stacy Simon

The US Food and Drug Administration (FDA) has approved a targeted therapy for treating certain adults with mantle cell lymphoma. A new drug is significant because this type of lymphoma has historically been challenging to treat. It tends to grow more quickly than other types of lymphoma, and hasn’t responded as well to standard treatments.

Calquence (acalabrutinib) is approved for people who have tried at least one other treatment and didn’t get better – or got better and then relapsed. It’s a kinase inhibitor, which is a type of targeted therapy that blocks certain proteins in the cancer cells. Blocking them helps keep the cells from dividing, and that can slow cancer growth.

The FDA based its approval on a trial of 124 people with mantle cell lymphoma who had received at least 1 treatment previously. All the participants received Calquence. The trial measured overall response rate – how many people’s tumors shrank or disappeared. In the trial, 81% had a response. About half of those who responded saw their tumors shrink and about half saw them disappear.

Calquence was evaluated using accelerated approval, priority review, and breakthrough therapy status – FDA programs designed to speed up the availability of drugs to treat serious diseases. As a condition of accelerated approval, the company that makes the drug must submit additional clinical information after approval, to demonstrate its benefit.

It was also granted orphan drug designation, which provides financial incentives to encourage the development of drugs for rare diseases. Only about 5% of lymphomas are mantle cell lymphomas.

The most common side effects of Calquence include headache; diarrhea; bruising; fatigue, muscle pain, and low blood counts.

Serious side effects are also possible. They include bleeding, infections, and irregular heartbeat. Some people who took Calquence developed another cancer. Women who are breastfeeding should not take Calquence because it may cause harm to a newborn baby.

Calquence is marketed by AstraZeneca Pharmaceuticals LP.

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