IMBRUVICA has been on the market for 9 years, 11 months, and 13 days as of October 26, 2023.
Initial FDA Approval and Market Entry
IMBRUVICA (ibrutinib) received its first approval from the U.S. Food and Drug Administration (FDA) on November 13, 2013. This initial approval was specifically for the treatment of Mantle Cell Lymphoma (MCL) in patients who had received at least one prior therapy. This marked its official entry into the pharmaceutical market.
Key Approval Milestones
The journey of IMBRUVICA on the market began with its approval for MCL, followed by an expansion of its indications to treat other blood cancers. Below is a summary of its initial significant FDA approvals:
| Date | Approval Type | Indication |
|---|---|---|
| Nov 13, 2013 | Approval | Mantle Cell Lymphoma (MCL) |
| Feb 12, 2014 | Approval | Chronic Lymphocytic Leukemia (CLL) |
Expanding Therapeutic Reach
Following its initial approval for MCL, IMBRUVICA quickly gained a second significant FDA approval on February 12, 2014, for the treatment of Chronic Lymphocytic Leukemia (CLL) in patients who have received at least one prior therapy. These early approvals established IMBRUVICA as a pivotal targeted therapy for several challenging blood cancers, enabling it to reach a broader patient population shortly after its market debut.
For more detailed information on IMBRUVICA's approval history and uses, you can refer to reputable sources such as Drugs.com.
