The approval of Calquence marks the first and only BTK inhibitor approved for the first-line treatment of MCL in the US.

The new first-line MCL indication gives Calquence a slice of the market of its own and could spur further growth of the drug, which grew 27% to $2.3 billion in the first nine months of 2024 and is AZ's third-largest cancer product. In the same period, Imbruvica fell around 7% to $2.5 billion while Brukinsa more than doubled to $1.8 billion.

AstraZeneca’s (AZ) Calquence (acalabrutinib) has been approved by the US Food and Drug Administration (FDA) as part of a combination treatment for mantle cell lymphoma (MCL).

The conversion of Calquence’s accelerated approval in mantle cell lymphoma comes a day before the drug was listed among the 15 products to be subject to IRA-prescripted price negotiations for Medicare this year.

Investing.com -- AstraZeneca (LON: AZN) in a stock exchange filing on Friday said that the FDA approved its drug Calquence (acalabrutinib) to treat previously untreated mantle cell lymphoma (MCL) in adults who cannot have a stem cell transplant.

WILMINGTON, Del. - The U.S. Food and Drug Administration (FDA) has granted approval to AstraZeneca (NASDAQ:AZN)'s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation.