AstraZeneca Secures Full FDA Approval for Lymphoma Treatment Selected by CMS
Full FDA Approval:
AstraZeneca has received full FDA approval for a lymphoma treatment that was selected by the Centers for Medicare & Medicaid Services (CMS)2.
Treatment Details:
The specific treatment and its details, such as the drug name and indications, are not provided in the available sources. However, AstraZeneca has a history of developing treatments for various types of lymphoma, including mantle cell lymphoma (MCL) and other blood cancers34.
Clinical Trials:
AstraZeneca is conducting clinical trials for various lymphoma treatments, including AZD4573, which is being studied as a monotherapy or in combination with other anti-cancer agents for relapsed/refractory peripheral T-cell lymphoma and classical Hodgkin lymphoma1.
Regulatory Background:
The FDA has previously granted accelerated approvals for AstraZeneca’s lymphoma treatments, such as Calquence (acalabrutinib) for MCL, which was approved in 20173.
CMS Involvement:
The CMS selection indicates that the treatment has met certain criteria for coverage under Medicare, reflecting its potential to address significant medical needs in lymphoma patients5.
Sources:
1. https://svse.www.astrazenecaclinicaltrials.com/study/D8231C00001/
2. https://www.biospace.com/fda/5-novel-fda-approvals-notched-in-2024
3. https://www.astrazeneca.com/media-centre/press-releases/2017/us-fda-approves-astrazenecas-calquence-acalabrutinib-for-adult-patients-with-previously-treated-mantle-cell-lymphoma-24102017.html
4. https://www.astrazenecaclinicaltrials.com/study/D822GC00001/
5. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=291