Novartis: granted Priority Review status by the FDA
(CercleFinance.com) - Novartis announced that the US Food and Drug Administration (FDA) has granted Scemblix (asciminib) priority review status for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase (Ph+ CML-CP).
The FDA grants priority review to drugs that treat serious or life-threatening diseases or conditions, and which, if approved, would provide significant improvements in safety or treatment efficacy.
Scemblix has already received Breakthrough Therapy designation for the treatment of newly diagnosed adult patients, and is currently under review as part of the FDA's Real-Time Oncology Review (RTOR) program.
The priority review is based on data from the ASC4FIRST Phase III study with Scemblix®, which demonstrated for the first time a significantly improved molecular response and a favorable safety and tolerability profile compared with standard therapies.
We welcome the FDA's decision to grant Scemblix Priority Review and Breakthrough Therapy status for patients with newly diagnosed CML, which underscores the significant need for additional effective, safe and tolerable treatment options, Novartis said.
ASC4FIRST data indicate that Scemblix, if approved, has the potential to fill a critical gap in CML by offering a highly effective treatment with a favourable safety and tolerability profile.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
The FDA grants priority review to drugs that treat serious or life-threatening diseases or conditions, and which, if approved, would provide significant improvements in safety or treatment efficacy.
Scemblix has already received Breakthrough Therapy designation for the treatment of newly diagnosed adult patients, and is currently under review as part of the FDA's Real-Time Oncology Review (RTOR) program.
The priority review is based on data from the ASC4FIRST Phase III study with Scemblix®, which demonstrated for the first time a significantly improved molecular response and a favorable safety and tolerability profile compared with standard therapies.
We welcome the FDA's decision to grant Scemblix Priority Review and Breakthrough Therapy status for patients with newly diagnosed CML, which underscores the significant need for additional effective, safe and tolerable treatment options, Novartis said.
ASC4FIRST data indicate that Scemblix, if approved, has the potential to fill a critical gap in CML by offering a highly effective treatment with a favourable safety and tolerability profile.
Copyright (c) 2024 CercleFinance.com. All rights reserved.