FDA, AstraZeneca and mantle cell lymphoma

AstraZeneca's Calquence gains FDA nod for 1L MCL treatment
AstraZeneca PLC (LSE/STO/Nasdaq: LON:AZN), a pharmaceutical giant with a market capitalization of $207.67 billion and impressive gross profit margins of 82.61%, announced that its drug Calquence (acalabrutinib),
AstraZeneca’s Calquence granted FDA approval in untreated mantle cell lymphoma
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).
AZ's Calquence gets first-line OK in mantle cell lymphoma
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 Gets Full FDA Approval for CMS-Selected Lymphoma Treatment
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.
CALQUENCE® (acalabrutinib) plus chemoimmunotherapy approved in the US for patients with previously untreated mantle cell lymphoma
AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation.
Calquence Combo Therapy Approved for Previously Untreated Mantle Cell Lymphoma
The Food and Drug Administration (FDA) has approved Calquence ® (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation.
FDA approves AstraZeneca's Calquence for untreated mantle cell lymphoma
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.
FDA Approves AstraZeneca's Calquence Combo Therapy For Untreated Mantle Cell Lymphoma
AstraZeneca's Calquence gains FDA approval for untreated mantle cell lymphoma, supported by data showing improved survival and reduced disease progression.
AstraZeneca lymphoma therapy Calquence gets expanded approval in the U.S.
AstraZeneca (NASDAQ:AZN) announced Friday that the U.S. FDA approved its Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) with chemoimmunotherapy as a first-line option for adults with mantle cell lymphoma,
FDA approves new MCL treatment by AstraZeneca
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.
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