Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that the US Food and Drug Administration (FDA) has granted priority review status to Scemblix (asciminib) for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML-CP). Scemblix, the first molecule to specifically target the ABL Myristoyl Pocket (STAMP inhibitor), is already approved in the US, EU, and other major markets for adult patients with Ph+ CML-CP who have previously received two or more tyrosine kinase inhibitors (TKIs).
The priority review was awarded based on the ASC4FIRST Phase III study, which demonstrated that Scemblix significantly improved molecular response compared to standard of care therapies, including imatinib and second-generation TKIs, in the first-line setting for Ph+ CML-CP. This development suggests that Scemblix’s current filing under the FDA’s Real-Time Oncology Review (RTOR) program may be expedited, following its previous Breakthrough Therapy Designation (BTD) for the same indication.
Securing approval for first-line treatment could significantly boost Scemblix’s sales, which grew 143% year-on-year in 2023, reaching USD 145 million in revenues.- Flcube.com
