FDA grants bempegal desleukin and Opdivo immunocombination therapy breakthrough drug qualification

recently announced jointly with BMS that the U.SFood andDrug(http://Administration (
FDA(http://has awarded bempegaldedesleukin (BEMMTR-214) and Opdivo (nivolumab, Navudan) immunocomas breakthrough drug qualification (BTD) for the treatment of previously treatable melanomasTHE FDA GRANTED NKTR-214-OPDIVO IMMUNE COMBINATION BTD, BASED ON ONGOING PHASE I/II CLINICAL STUDY PIVOT-02 METASTATIC (PHASE IV) MELANOMA PATIENT COHORT DATA, WHICH WAS PRESENTED AT THE 2019 ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO)The results showed that as of March 29, 2019, the median follow-up was 12.7 months, and the total remission rate (ORR) was 53% (20/38), the total remission rate (CR) was 34% (13/38), and the disease control rate (DCR:CR-PR-S-SD) was 4 percentIn the subgroups where the baseline PD-L1 negative (n-L1), PD-L1 positive (n-L1), PD-L1 status unknown (n-3), lactic acid dehydrogenase higher than the upper limit of normal reference value (LDH-ULN, n-11), liver transfer (n-10), the total remission rate was 43%, 62%, 33%, 45%, 50%In September 2016, Boxei Squibb and Nektar reached a clinical collaboration to evaluate opdivo/NKTR-214 combination therapy for the treatment of a wide range of types of cancerIn February 2018, the two sides reached a global strategic development and commercialization partnership totalling $3.6 billion to develop a combination of NKTR-214 and Opdivo and Opdivo-Yervoy in more than 20 indications for nine tumor types, as well as a combination of other anticancer drugs from 2companies(http://or third partiesAt present, NKTR-214/Opdivo immunocombination therapy for melanoma and renal cell carcinoma (RCC) has entered Phase III clinical