FDA Converts Keytruda Qlex TMB-High Approval to Traditional; Other Accelerated Files Pending
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On October 16, 2026, the FDA granted traditional approval to Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for adults and patients 12 years and older with unresectable or metastatic TMB-H (≥10 mut/Mb) solid tumors, as determined by an FDA-approved test, that progressed after prior treatment with no satisfactory alternative options. The accelerated approval for this formulation was filed on September 19, 2025. Separately, Lunsumio Velo (mosunetuzumab-axgb) for relapsed or refractory follicular lymphoma after two or more systemic lines, filed December 19, 2025, remains under review, as do three Brukinsa (zanubrutinib) accelerated approvals dated June 10, 2025 covering mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma with obinutuzumab. The FDA also maintains a list of oncology accelerated approvals with verified clinical benefit, spanning drugs from Keytruda and Opdivo to Tecvayli and Imdelltra across solid tumors and blood cancers.
Written by a model from the reports · updated 3 hours ago
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- fda.govVerified Clinical Benefit | Cancer Accelerated Approvals
The FDA lists oncology accelerated approvals that have since had clinical benefit verified, spanning drugs from Keytruda and Opdivo to Tecvayli and Imdelltra. Each entry pairs the original accelerated approval date with its verification date, for example Keytruda in TMB-high solid tumors and Breyanzi in relapsed or refractory follicular lymphoma. The list covers indications across solid tumors and blood cancers, including Retevmo in RET fusion solid tumors, Tecvayli in multiple myeloma and Jaypirca in CLL/SLL.
- fda.govOther | Cancer Accelerated Approvals
FDA granted traditional approval on 10/16/2026 to Keytruda Qvantig... correction: Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for adults and patients 12 years and older with unresectable or metastatic TMB-H (≥10 mut/Mb) solid tumors, as determined by an FDA-approved test, that progressed after prior treatment with no satisfactory alternative options. The accelerated approval for this formulation was filed 9/19/2025. Separately, Lunsumio Velo (mosunetuzumab-axgb) for relapsed or refractory follicular lymphoma after two or more systemic lines, filed 12/19/2025, remains ongoing, as do three Brukinsa (zanubrutinib) accelerated approvals dated 6/10/2025 covering MCL, MZL and FL with obinutuzumab.
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