J&J's daratumumab gets "Breakthrough" status; GSK's trametinib delayed by FDA

The US Food and Drug Administration has granted “Breakthrough Therapy Designation” for health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Research & Development’s daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and IMiD.

Daratumumab is an investigational human CD38 monoclonal antibody and was discovered by the Danish company Genmab (OMX: GEN). Last year, Janssen Biotech and Genmab entered an agreement which granted Janssen an exclusive worldwide license to develop and commercialize daratumumab potentially worth more than $1.1 billion to Genmab (The Pharma Letter August 31, 2012).

This FDA designation marks the second oncology compound within the Janssen pipeline to receive Breakthrough status in the last three months. Earlier this year, the company announced that the FDA granted Breakthrough Therapy Designations for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib as a monotherapy for three B-cell malignancies: in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with deletion of the short arm of chromosome 17 (del17p), in patients with relapsed or refractory Mantle Cell Lymphoma (TPLs February 14 and April 9) who have received prior therapy, and in patients with Waldenstrom's macroglobulinemia (WM). Janssen and Pharmacyclics are co-developing and will co-commercialize ibrutinib.