Across both groups, the ORR was 36% (95% CI, 30-43), and 58% of patients had a DOR of at least 12 months.<\/p>\n
Safety Profile<\/p>\n
The safety profile of pembrolizumab monotherapy for the updated indication was consistent with the known safety profile of the agent. The prescribing information includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.<\/p>\n
Dosing and Administration<\/p>\n
For the updated indication, the recommended dose of pembrolizumab monotherapy is 200 mg every 3 weeks or 400 mg every 6 weeks in adults, continued until disease progression, unacceptable toxicity, or up to 24 months. Pediatric patients should receive 2 mg\/kg every 3 weeks, up to a maximum of 200 mg, using the same treatment duration limits. Dosing and administration information for pembrolizumab and berahyaluronidase alfa-pmph is available in its prescribing information.<\/p>\n
The FDA review used the Assessment Aid, a voluntary submission from the applicant intended to facilitate the agency\u2019s assessment.<\/p>\n
Prior Regulatory History<\/p>\n
The FDA granted accelerated approval to pembrolizumab<\/a> on June 16, 2020, for adult and pediatric patients with unresectable or metastatic TMB-H solid tumors, defined as \u226510 mut\/Mb, that had progressed following prior treatment and had no satisfactory alternative treatment options.\u00b2 That approval was based on KEYNOTE-158 data in 102 patients with TMB-H tumors, in whom the ORR was 29% (95% CI, 21-39) and 57% of responses lasted at least 12 months. The FoundationOne CDx assay was identified as the companion diagnostic.<\/p>\n The subcutaneous formulation<\/a>, pembrolizumab and berahyaluronidase alfa-pmph, was approved on September 19, 2025, for adult and pediatric patients 12 years and older across the solid tumor indications approved for intravenous pembrolizumab.\u00b3<\/p>\n REFERENCES1. FDA grants traditional approval for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indication. News release. FDA. October 16, 2026. Accessed October 22, 2026. https:\/\/tinyurl.com\/mr287hdp<\/a>2. FDA approves pembrolizumab for adults and children with TMB-H solid tumors. News release. FDA. June 16, 2020. Accessed October 22, 2026. https:\/\/tinyurl.com\/uwx4px28<\/a>2. FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection. News release. FDA. September 19, 2025. Accessed October 22, 2026. https:\/\/tinyurl.com\/yhduvdba<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"Across both groups, the ORR was 36% (95% CI, 30-43), and 58% of patients had a DOR of…\n","protected":false},"author":2,"featured_media":654170,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[163,85,46],"class_list":["post-654169","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health","tag-health","tag-il","tag-israel"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/654169","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=654169"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/654169\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/654170"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=654169"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=654169"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=654169"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}