Daiichi Sankyo Submits Yescarta NDA to Japan MHLW

Country: JAPAN | Region: ASIA & SOUTH PACIFIC | Type: Drug Approval | Keywords: #cartcelltherapy #cellandgenetherapy #daiichisankyo #genetherapy #gilead #kite
#lymphoma #mhlw #newdrugapplication

PRICENTRIC BRIEF:

  • Daiichi Sankyo has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor, and Welfare (MHLW) for its CAR T-cell therapy Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed/refractory (R/R) diffused large B-cell lymphoma (DLBCL) and related lymphomas
  • The NDA for Yescarta is based on previous trial data that was conducted globally by Kite along with results from a Phase 2 bridging study conducted by Daiichi Sankyo
  • Both trials included patients with four aggressive types of relapsed/refractory B-cell lymphomas including diffuse large B cell lymphoma (DLBCL); primary mediastinal B-cell lymphoma (PMBCL); transformed follicular lymphoma (TFL); and high-grade B cell lymphoma

THE DETAILS

TOKYO, Japan – Daiichi Sankyo has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor, and Welfare (MHLW) for its CAR T-cell therapy Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed/refractory (R/R) diffused large B-cell lymphoma (DLBCL) and related lymphomas.

The NDA for Yescarta is based on previous trial data that was conducted globally by Kite along with results from a Phase 2 bridging study conducted by Daiichi Sankyo.

Both trials included patients with four aggressive types of relapsed/refractory B-cell lymphomas including diffuse large B cell lymphoma (DLBCL); primary mediastinal B-cell lymphoma (PMBCL); transformed follicular lymphoma (TFL); and high-grade B cell lymphoma.

Wataru Takasaki, PhD, Corporate Officer, Head of Oncology Function and Head of R&D Division in Japan, Daiichi Sankyo, said, “We are pleased to confirm submission of the NDA for axicabtagene ciloleucel following positive topline results from the phase 2 bridging study in Japan.

“We will continue to work with regulatory authorities to develop this important new cell therapy for eligible patients in Japan who need additional treatment options for relapsed or refractory DLBCL and related lymphomas.”

 

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