J&J (JNJ) Seeks EU Approval For Darzalex's Expanded Use
Zacks Investment Research | Aug 23, 2016 09:10PM ET
Johnson & Johnson’s (NYSE:JNJ) Janssen-Cilag International NV announced that it has filed a type II variation application with the European Medicines Agency seeking label expansion for its immunotherapy, Darzalex, in combination with Revlimid (an immmunomodulatory agent) and dexamethasone, or Velcade (a proteasome inhibitor/PI) and dexamethasone, for the treatment of adult patients with relapsed multiple myeloma patients who have received at least one prior therapy.
Darzalex gained conditional approval in the EU in May 2016 for use as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunotherapy agent and who have demonstrated disease progression on the last therapy.
The EU filing came a week after the submission of a supplemental biologics license application for a label expansion of Darzalex to the FDA. The company is looking to get Darzalex approved in combination with Revlimid and dexamethasone, or Velcade and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
We note that last month, Darzalex was granted Breakthrough Therapy status by the FDA for this indication. This marks the second time that the drug was granted such status in the U.S. This status expedite the process of development and review of drugs that are being evaluated for the treatment of serious or life-threatening diseases, where preliminary clinical evidence indicates that the drug may provide substantial improvement over existing therapies.
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