Calquence (acalabrutinib) fda approval history?

Here’s the FDA approval history for Calquence (acalabrutinib) in the United States, by key approvals.

Calquence (acalabrutinib) — FDA approval timeline

• October 31, 2017: Original FDA approval
  
  • Indication: Mantle Cell Lymphoma (MCL) that had relapsed or progressed after at least one prior therapy.
    
    
• March 28, 2019: New indication added
  
  • Indication: Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), with or without deletion 17p (del(17p)), who have been treated previously (relapsed/refractory).
    
    
• January 12, 2021: Expanded/updated indication for CLL/SLL
  
  • Indication: Previously untreated CLL/SLL (treatment-naïve).
    
    
• June 22, 2023: New indication added
  
  • Indication: Relapsed or refractory Follicular Lymphoma (FL) after at least two prior systemic therapies.
    
    > Note: Indications can sometimes include specific eligibility language (e.g., “relapsed/refractory,” “with/without del(17p),” prior therapies). If you tell me the exact indication you care about, I can narrow this to the most relevant FDA labeling/approval entry.
    
    

If you want, I can also add:

• the approval letters/press releases for each date,
  
• key trial names tied to each approval (e.g., ELEVATE-TN, ELEVATE-RR, ACE-LY-4),
  
• whether approvals were accelerated vs regular and whether label language later changed.
  
  Which indication are you focusing on: MCL, CLL/SLL, or follicular lymphoma?