Other | Cancer Accelerated Approvals
Other | 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.
Source: fda.gov · fda.gov