FDA D.I.S.C.O. Burst Edition: FDA approvals of Tecentriq (atezolizumab) for unresectable or metastatic alveolar soft part sarcoma, and Krazati (adagrasib) for KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
Regulatory approval news: In an FDA D.I.S.C.O. Burst Edition update, the FDA reported approvals in December 2022 for two oncology agents. On Dec 9, 2022, atezolizumab (Tecentriq) was approved for unresectable or metastatic alveolar soft part sarcoma in adults and pediatric patients aged ≥2 years, supported by a single-arm study (ORR 24%). On Dec 12, 2022, the FDA granted accelerated approval to adagrasib (Krazati) for previously treated KRAS G12C–mutated locally advanced/metastatic NSCLC (ORR 43%; median DOR 8.5 months).
FDA D.I.S.C.O. Burst Edition: Tecentriq and Krazati approvals (regulatory approval)
Event date: Dec 9, 2022 (FDA communication)
Atezolizumab (Tecentriq) in alveolar soft part sarcoma
On Dec 9, 2022, the FDA approved atezolizumab for adult and pediatric patients ≥2 years with unresectable or metastatic alveolar soft part sarcoma.
Efficacy was evaluated in Study ML39345 (open-label, single-arm; n=49). Patients had ECOG PS ≤2 and disease incurable by surgery. Overall response rate (ORR) was 24% by independent review (RECIST v1.1). Among 12 responders, 67% had response duration ≥6 months and 42% had duration ≥12 months.
Common adverse reactions (≥15%) included musculoskeletal pain, fatigue, rash, cough, nausea, headache, hypertension, vomiting, constipation, dyspnea, dizziness, hemorrhage, diarrhea, pyrexia, hypothyroidism, arrhythmia, and others.
Adagrasib (Krazati) in KRAS G12C-mutated NSCLC
On Dec 12, 2022, the FDA granted accelerated approval to adagrasib for adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC (FDA-approved test) after ≥1 prior systemic therapy.
Approval was based on KRYSTAL-1 (multicenter, single-arm, open-label). In 112 previously treated patients, ORR was 43% with median duration of response 8.5 months.
FDA also approved QIAGEN therascreen KRAS RGQ PCR kit (tissue) and Agilent Resolution ctDx FIRST Assay (plasma) as companion diagnostics; if plasma is negative, tumor tissue testing is recommended.