Genmab A/S GNMSF announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) rendered a negative opinion for Arzerra as a maintenance therapy for patients suffering from relapsed chronic lymphatic leukemia (CLL).
Currently, Arzerra is approved in the EU in combination with Leukeran or Levact for the treatment of patients with CLL who have not received prior therapy and are not eligible for Fludara-based therapy.
Additionally, the drug is approved in the U.S. in combination with Leukeran for the treatment of previously untreated patients with CLL for whom Fludara-based therapy is considered inappropriate as well as for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.
We note that Arzerra is marketed under a collaboration agreement between Genmab and Novartis AG NVS, wherein Novartis holds the rights to develop Arzerra for autoimmune indications, including multiple sclerosis.
Genmab also has a collaboration agreement with Johnson & Johnson’s JNJ Janssen Biotech, Inc. for the development, manufacture and commercialization of Darzalex. Darzalex is currently in several phase III studies in relapsed and frontline settings while additional studies are ongoing or being planed for other malignant and pre-malignant diseases on which CD38 is expressed, like smoldering myeloma, non-Hodgkin’s lymphoma and a solid tumor.
Last year, Darzalex got accelerated FDA approval for the treatment of multiple myeloma patients who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.
Meanwhile, 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.
Genmab is a Zacks Rank #2 (Buy) stock. Another favorably ranked stock in the health care sector is ANI Pharmaceuticals, Inc. ANIP, sporting a Zacks Rank #1 (Strong Buy).
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