FDA grants full approval to Keytruda and Keytruda Qlex for TMB-high advanced solid tumours with updated biomarker threshold
The FDA has converted Keytruda's tumour-mutational-burden-high solid tumour indication to traditional approval, extending the authorisation to Keytruda Qlex and updating the biomarker threshold.
Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) are authorised for previously treated adults and children with unresectable or metastatic TMB-high solid tumours, defined as at least 13 mutations per megabase using an FDA-authorised test, when satisfactory alternative treatments are unavailable.
The decision replaces an earlier accelerated approval and raises the biomarker threshold from 10 to 13 mutations per megabase, supported by KEYNOTE-158 data showing a 36% objective response rate among 220 patients, with 58% of responders maintaining responses for at least 12 months.
Field | Content |
Article Type | Approvals |
Regulatory Authority | U.S. Food and Drug Administration |
Regulatory Decision | Traditional approval replacing an earlier accelerated approval |
Approval Date | 16 October 2026 |
Company | Merck & Co. |
Approved Products | Keytruda; Keytruda Qlex |
Keytruda Active Ingredient | Pembrolizumab |
Keytruda Qlex Active Ingredients | Pembrolizumab and berahyaluronidase alfa-pmph |
Therapeutic Area | Oncology |
Approved Indication | Previously treated unresectable or metastatic tumour-mutational-burden-high solid tumours without satisfactory alternative treatment options |
Patient Population | Adults and children meeting the approved biomarker and prior-treatment criteria |
Biomarker | Tumour mutational burden-high (TMB-H) |
Updated TMB Threshold | At least 13 mutations per megabase |
Previous TMB Threshold | At least 10 mutations per megabase |
Biomarker Testing | FDA-authorised test |
Prior Treatment Requirement | Previously treated disease |
Alternative Treatment Requirement | No satisfactory alternative treatment options |
Supporting Clinical Study | KEYNOTE-158 |
Study Population | 220 patients in the reported efficacy analysis |
Objective Response Rate | 36% |
Response Durability | 58% of responders maintained responses for at least 12 months |
Threshold Change Rationale | Efficacy was not confirmed in the subgroup with TMB of 10 to below 13 mutations per megabase |
Regulatory History | Conversion of an earlier accelerated approval to traditional approval with a revised biomarker threshold |
Geography | United States |
What Happened | The FDA granted traditional approval to Keytruda and Keytruda Qlex for eligible patients with TMB-high unresectable or metastatic solid tumours. |
Why It Matters | The decision confirms a biomarker-directed, tumour-agnostic treatment indication while refining the population based on observed efficacy. |
Clinical Evidence | KEYNOTE-158 reported a 36% objective response rate in 220 patients and response duration of at least 12 months in 58% of responders. |
Key Takeaway | Traditional approval now applies to Keytruda and Keytruda Qlex for eligible TMB-high advanced solid tumours using a threshold of at least 13 mutations per megabase. |
What to Watch | Updated biomarker testing practices, clinical guideline revisions, treatment selection, real-world outcomes and adoption of the revised threshold. |
Primary Source | U.S. Food and Drug Administration |
Primary Source URL | https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph |
Relevant Date | 16 October 2026 |
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