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Bristol-Myers, Nektar drug combo gets FDA breakthrough status

Nektar Therapeutics and Bristol-Myers Squibb Co. said the U.S. Food and Drug Administration granted breakthrough-therapy designation to a combination of NKTR-214 and Bristol-Myers' Opdivo for the treatment of patients with an advanced form of untreated skin cancer.

Opdivo, or nivolumab, is a programmed cell death protein 1, or PD-1 inhibitor, that boosts the immune system's ability to kill cancer cells. Nektar's NKTR-214, or bempegaldesleukin, is designed to activate specific cancer-fighting immune cells directly in the tumor and increase expression of PD-1 on these immune cells.

The U.S. regulator granted the designation based on data from an ongoing phase 1/2 clinical trial called Pivot-02. Results from that study issued in June 2018 showed that tumors either partially or completely shrank after treatment with the NKTR-214 combo.

Breakthrough-therapy designation will expedite the development and review of the drug combination for untreated cancer that cannot be removed completely through surgery or metastatic melanoma, which is cancer that starts in the cells that produce color pigment and later spreads beyond its original skin location. The designation is granted to new therapies that treat serious or life-threatening conditions and are potentially better than existing therapies.

New York-based Bristol-Myers and Nektar agreed to a $1.85 billion strategic development and commercialization collaboration to develop medicines, including NKTR-214, for multiple cancer types in February 2018.

San Francisco-based Nektar develops drug candidates for cancer, auto-immune disease and chronic pain.