FDA accepts application for license to supplement biologics for its heavy immunotherapy Keytruda

recently, MSD announced that itFDA(receiving a supplementary biologic license (sBLA) for its heavy immunotherapy Keytruda (pembrolizumab) to treat adults and children with recurrent pre-localized or metastatic merinoma (Merkel cell carcinoma, MCC)The FDA also qualifies the application for priority review and is expected to respond by December 28Previously, in July 2017, the FDA granted Keytruda a ground-breaking treatment for the conditionkey immunotherapy for KeytrudaKeytruda as a heavyweight immunotherapy that has demonstrated a wide range of therapeutic potential and has become a major immunotherapy for MercadoIt selectively blocks PD-1 from binding to its ligands PD-L1 and PD-L2, allowing T lymphocytes to recognize and kill cancer cellsKeytruda has been approved for the treatment of a variety of cancers, such as melanoma, lung cancer, head and neck cancer, classic Hodgkin's lymphoma, primary isolation of large B-cell lymphoma, urinary maltose cancer, microsatellite instability (MSI-H) cancer, stomach cancer, and advanced cervical cancerrelated research
This extended indication spending application is based on the one-arm, open-label KEYNOTE-017 Clinical Phase 2 ClinicalTrial(results, which were presented at the 2018 annual meeting of the American Academy of Clinical Oncology (ASCO)The main endpoints of the KEYNOTE-017 trial were total mitigation rates (ORR), and secondary endpoints included no progression lifetime (PFS), total lifetime (OR), and mitigation duration (DOR)Fifty patients with advanced or metastasis received a dose of 2 mg/kg, with Keytruda injections every three weeksresults showed that in a tracking assessment of an average of 14.9 months, the ORR per independent assessment was 56%, including a full remission rate (CRR) of 24% and a partial mitigation rate of 32% (PRR)Another 10 percent of patients remained stable, and only 32 percent had progress The average PFS was 16.8 months, well above the average PFS (3.1-4.6 months) using chemotherapy as a first-line therapy