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Nektar and BMS Receive the US FDA's Breakthrough Designation for Bempegaldesleukin (NKTR-214) + Opdivo (nivolumab) to Treat Advanced Melanoma

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Nektar and BMS Receive the US FDA's Breakthrough Designation for Bempegaldesleukin (NKTR-214) + Opdivo (nivolumab) to Treat Advanced Melanoma

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  • The FDA’s BT designation is based on ongoing P-I/II PIVOT-02 study assessing the doublet therapy in patients with metastatic melanoma. FDA’s BT designation is to expedite the development of medicine targeting life-threatening diseases
  • In Feb 2018- BMS signed a WW development and commercialization agreement with Nektar for its Bempegaldesleukin
  • Nektar’s Bempegaldesleukin is a therapy targeting CD122 receptors- activating CD8+ effector T cells and NK cells and is being evaluated in P-III study in combination with Opdivo vs Opdivo in patients with 1L advanced melanoma. Opdivo is a PD-1 immune checkpoint inhibitor harnessing the body’s immune system by restoring anti-tumor response

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Ref: BMS | Image: BMS 


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