米・Merck社が、ペムブロリズマブについて、再発または治療抵抗性の原発性縦隔B細胞性リンパ腫に対する適応拡大申請が米食品医薬品局(FDA)により受理されたと発表【米・Merck】

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

KEYTRUDA is the First Anti-PD-1 Therapy Approved for Adult and Pediatric Patients with Refractory PMBCL or Who Have Relapsed After Two or More Prior Lines of Therapy

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA®, the company’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. This indication is approved under the FDA’s accelerated approval regulations based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for the treatment of patients with PMBCL who require urgent cytoreductive therapy. With this indication, KEYTRUDA becomes the first anti-PD-1 therapy to be approved for the treatment of PMBCL, a type of non-Hodgkin lymphoma. This is the second indication for KEYTRUDA for the treatment of a hematologic malignancy.

 

 

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