Ibrutinib Receives Orphan Drug and Breakthrough Therapy Designation for cGVHD
The drug received breakthrough therapy and orphan drug designation as a monotherapy for the treatment of chronic graft-versus-host-disease.
On June 29, 2016 FDA granted Imbruvica (ibrutinib) Breakthrough Therapy designation and Orphan Drug designation as a monotherapy for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after failure or one more lines of systematic therapy. This is the fourth Breakthrough Therapy designation for the drug, Reuters noted in a brief.
Imbruvica works by blocking Bruton’s tyrosine kinase (BTK). The BTK protein transmits signals that tell B cells to mature and multiply. Imbruvica targets and blocks BTK, inhibiting cancerous B cells to survive and spread. Imbruvica is currently being studied alone in combination with other treatments in several blood and solid tumor cancers and other serious illnesses.
Imbruvica is co-developed and commercialized by Pharmacyclics, an AbbVie company, and Janssen Biotech. AbbVie acquired Pharmacyclics and Imbruvica in March 2015 for $261.25 per share. AbbVie also acquired Stemcentrx in late April 2016. Both acquisitions are a strategic move for the company, which is looking to expand its oncology pipeline.
Source: AbbVie, Janssen Pharmaceuticals
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
