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Novartis (NVS) Gets Breakthrough Therapy Tag for Leukemia Drug

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Novartis AG (NVS - Free Report) announced that asciminib — a novel investigational treatment specifically targeting the ABL myristoyl pocket (STAMP) — has been granted Breakthrough Therapy designation (BTD) by the FDA for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs).

Breakthrough Therapy designation is granted to medicines being evaluated for serious conditions where early clinical evidence indicates the potential for substantial improvement over available therapy

Shares of the company have declined 6.6% in the past year against the industry’s growth of 2.5%.

The Breakthrough Therapy designation was based on the phase III study (ASCEMBL) study, whereinasciminib met the primary endpoint. Asciminib was evaluated in patients with Ph+ CML-CP, previously treated with two or more tyrosine-kinase inhibitors. In the primary analysis, treatment with asciminib led to significant superiority in major molecular response rate at 24 weeks versus Pfizer’s (PFE - Free Report) Bosulif (bosutinib), thereby meeting the study’s primary endpoint. The designation was also based on a phase I study that included patients with Ph+ CML, some of them harboring the T315I mutation.

The FDA previously granted Fast Track designation to asciminib and Novartis plans for a submission in the first half of 2021 for review under the FDA Oncology Center of Excellence Real-Time Oncology Review program.

Zacks Rank

Novartis currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector include AbbVie Inc. (ABBV - Free Report) and Johnson & Johnson (JNJ - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

AbbVie’s earnings per share estimates have increased from $12.12 to $12.41 for 2020 and from $13.38 to $13.76 for 2021 over the past 60 days. Shares of the company have increased 12.8% in the past year.

Johnson & Johnson’s earnings per share estimates have increased from $8.90 to $9.48 for 2020 and from $9.71 to $10.17 for 2021 over the past 60 days. Shares of the company have increased 8.6% in the past year.

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