October 29, 2024- Today, the U.S. Food and Drug Administration has granted accelerated approval to Asciminib(Scemblix) for the treatment of adults with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in the chronic phase.
“The effectiveness of asciminib in newly diagnosed Ph+ CML in the chronic phase was assessed in the ASC4FIRST trial (NCT04971226), a multicenter, randomized, active-controlled, and open-label study. In this trial, 405 patients were randomized in a 1:1 ratio to receive either asciminib or an investigator-selected tyrosine kinase inhibitor (IS-TKI), which could be imatinib, nilotinib, dasatinib, or bosutinib. The primary endpoint was the major molecular response (MMR) rate at week 48. Results showed an MMR rate of 68% (95% CI: 61–74) with asciminib, compared to 49% (95% CI: 42–56) with IS-TKIs, representing a 19% difference (95% CI: 10–28; p < 0.001). Among patients treated within the imatinib subgroup, MMR rates were 69% (95% CI: 59–78) for asciminib versus 40% (95% CI: 31–50) for IS-TKIs, with a 30% difference (95% CI: 17–42; p < 0.001).
In the pooled safety population, which included patients both newly diagnosed and previously treated for Ph+ CML in the chronic phase, the most frequent adverse reactions (≥20%) were musculoskeletal pain, rash, fatigue, upper respiratory tract infection, headache, abdominal pain, and diarrhea. The most commonly observed laboratory abnormalities (≥40%) among newly diagnosed patients were reductions in lymphocyte count, leukocyte count, platelet count, neutrophil count, and corrected calcium levels.
The recommended dosage for Asciminib is either 80 mg taken orally once daily at roughly the same time each day or 40 mg taken orally twice daily at approximately 12-hour intervals.
Everest Pharmaceuticals launched the generic version of SCEMBLIX under ASCIMIB brand name in 01stJuly 2022.
