US regulators’ use of a speedy clearance pathway for a new frontline indication for asciminib for chronic myeloid leukemia (CML) has raised questions due to the number of medications already available ...

The major molecular response rate was 68% with asciminib and 49% with IS-TKIs (difference, 19% [95% CI, 10-28]; P .001). The Food and Drug Administration (FDA) has granted accelerated approval to ...

Bosutinib approved for chronic myelogenous leukemia The FDA has approved bosutinib (Bosulif, Pfizer) for patients with chronic, accelerated or blast phase Philadelphia chromosome positive CML, who are ...

(RTTNews) - Novartis (NVS) announced that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration for adult patients with newly diagnosed Philadelphia ...

Novartis (NVS) announced that Scemblix was granted accelerated approval by the U.S. Food and Drug Administration for adult patients with newly diagnosed Philadelphia chromosome-positive chronic ...

Ponatinib plus chemotherapy received FDA accelerated approval for first-line treatment of Ph+ ALL, showing superior efficacy over imatinib in the PhALLCON study. The PhALLCON trial demonstrated a 30% ...

Findings showed 30% of patients in the ponatinib arm achieved MRD-negative complete response rate at the end of the induction phase vs 12% of those in the imatinib arm. The Food and Drug ...