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FDA Grants Accelerated Approval For J&J’s Cancer Drug Darzalex

Edit: Shenzhen OK Biotech Technology Co., Ltd. (SZOB)    Date: Nov 17, 2015

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FDA grants accelerated approval for J&J’s cancer drug Darzalex

A Johnson & Johnson drug won Food and Drug Administration approval Monday for treating the incurable blood cancer multiple myeloma in patients who’ve failed prior therapies and have few options left.


Darzalex is the first biologic drug and first monoclonal antibody – a genetically engineered drug created to target diseased tissue and spare healthy cells – approved for multiple myeloma. According to the National Cancer Institute there will be an estimated 26,850 new cases of multiple myeloma and 11,240 related deaths in the United States by the end of this year.


Darzalex injection is given as an infusion.


“Targeting proteins that are found on the surface of cancer cells has led to the development of important oncology treatments”, Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, said in a statement.\


The approval was based on data from two open-label clinical trials.


Genmab said a pivotal phase II MMY2002 (SIRIUS) study showed treatment with Darzalex resulted in an overall response rate (ORR) of 29.2 percent in patients who received a median of five prior lines of therapy, including a PI and an IMiD. Stringent complete response (sCR) was reported in 2.8 percent of patients, very good partial response (VGPR) was reported in 9.4 percent of patients, and partial response (PR) was reported in 17 percent of patients.


The FDA noted that as a condition of the accelerated approval, Janssen will be required to conduct a multicenter, randomized trial establishing the superiority of daratumumab over standard therapy to verify and describe the clinical benefit of daratumumab. In addition, women who are pregnant should not use Darzalex, while women hoping to become pregnant should use effective contraceptives during and for at least three months after treatment. The drug will be marketed as Darzalex.


The infused drug is administered once weekly for the first two months and, if the patient continues responding, every two weeks for the next four months and then once per month. That’s before any discounts insurers or other payers negotiate with J&J. More serious side effects were lowered amounts of white blood cells, red blood cells or blood platelets. The most common all-grade adverse events were fatigue (39.6 percent), anemia (33 percent), nausea (29.2 percent), thrombocytopenia (25.5 percent), back pain (22.6 percent), neutropenia (22.6 percent) and cough (20.8 percent).


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