Janssen Biotech has submitted a supplemental biologics license application (sBLA) for Darzalex (daratumumab) to the US Food and Drug Administration to expand its indication. The company seeks to use daratumumab in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, or bortezomib (a proteasome inhibitor [PI]) and dexamethasone, for patients with multiple myeloma who have received at least one prior therapy. Daratumumab received breakthrough therapy designation from the FDA for this pending indication on July 25, 2016.

Janssen has also submitted a request for priority review of this sBLA. In November 2015, Darzalex was approved by the FDA as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.

In May 2016, the European Commission granted conditional approval to Darzalex as a monotherapy for adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.

Janssen Biotech formed a collaboration in August 2012 with Genmab, which granted Janssen an exclusive license to develop, manufacture and commercialize the drug worldwide. Darzalex is commercialized in the US by Janssen Biotech.

Source: Johnson & Johnson