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FDA Sanctions Sotorasib and Panitumumab for KRAS G12C-Mutated mCRC
On January 16, 2025, the Food and Drug Administration granted conventional approval to acalabrutinib (Calquence, AstraZeneca) in combination with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are not candidates for autologous hematopoietic stem cell transplantation (HSCT). The FDA has granted conventional clearance for acalabrutinib as a monotherapy for people with previously treated mantle cell lymphoma (MCL). Acalabrutinib obtained expedited clearance for this indication in 2017. Effectiveness and Safety The efficacy was assessed in ECHO (NCT02972840), a randomized, double-blind, placebo-controlled, multicenter trial involving 598 patients with untreated mantle cell lymphoma (MCL) aged 65 years or older, who were not candidates for hematopoietic stem cell transplantation (HSCT). Patients were randomized in a 1:1 ratio to receive acalabrutinib in conjunction with bendamustine and rituximab (acalabrutinib + BR) or a placebo alongside BR. The efficacy was determined by progression-free survival (PFS), evaluated by an independent review committee. With a median follow-up of 49.8 months, progression-free survival (PFS) was significantly prolonged in the acalabrutinib group (hazard ratio 0.73 [95% CI: 0.57, 0.94], p-value 0.016). The median progression-free survival (PFS) was 66.4 months (95% CI: 55.1, not estimable) in the acalabrutinib plus BR group and 49.6 months (95% CI: 36.0, 64.1) in the placebo plus BR group. Severe adverse events were observed in 69% of patients receiving acalabrutinib in combination with BR, whereas fatal adverse reactions occurred in 12% of cases. Significant adverse events documented in ≥2% of patients included pneumonia, COVID-19, fever, secondary primary malignancy, rash, febrile neutropenia, atrial fibrillation, sepsis, and anemia. The advised dosage of acalabrutinib is 100 mg administered orally approximately every 12 hours until disease progression or intolerable toxicity occurs.
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About Sai Sree
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