BRIEF-Novartis Receives FDA Breakthrough Therapy Designations For Asciminib

Feb 8 (Reuters) - Novartis AG NOVN.S:

• NOVARTIS RECEIVES FDA BREAKTHROUGH THERAPY DESIGNATIONS FOR INVESTIGATIONAL STAMP INHIBITOR ASCIMINIB (ABL001) IN CHRONIC MYELOID LEUKEMIA

• DESIGNATION IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA (CML) RESISTANT OR INTOLERANT TO PRIOR TREATMENTS BASED ON POSITIVE DATA FROM PIVOTAL PHASE III ASCEMBL TRIAL EVALUATING ASCIMINIB, AN INVESTIGATIONAL TREATMENT SPECIFICALLY TARGETING ABL MYRISTOYL POCKET (STAMP

• DESPITE ADVANCES IN CML CARE, MANY PATIENTS ARE AT RISK OF DISEASE PROGRESSION, AND SEQUENTIAL TKI THERAPY MAY BE ASSOCIATED WITH INCREASED RESISTANCE AND INTOLERANCE

• BREAKTHROUGH THERAPY DESIGNATION IS GRANTED TO MEDICINES BEING EVALUATED FOR SERIOUS CONDITIONS WHERE EARLY CLINICAL EVIDENCE INDICATES POTENTIAL FOR SUBSTANTIAL IMPROVEMENT OVER AVAILABLE THERAPY

• ASCIMINIB IS IN DEVELOPMENT ACROSS MULTIPLE TREATMENT LINES OF CML; FIRST REGULATORY FILING IN PRE-TREATED PATIENTS ANTICIPATED IN FIRST HALF OF 2021 UNDER US FDA REAL-TIME ONCOLOGY REVIEW PROGRAM

Further company coverage: NOVN.S

(Berlin Speed Desk)

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