Novartis (NVS) Chronic Myeloid Leukemia Drug Approved by EC
Novartis NVS announced that the European Commission (EC) has approved Scemblix (asciminib) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors (TKIs).
The approval was based on positive results from the phase III ASCEMBL study, in which Scemblix nearly doubled the major molecular response rate as compared to Bosulif (bosutinib), with a more than three times lower discontinuation rate due to adverse reactions at 24 weeks and confirmed at 96 weeks.
The approval was already in the cards as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion for the same in June.
Per the company, Scemblix is the first CML treatment that acts as a STAMP inhibitor, specifically targeting the ABL myristoyl pocket.
Last year, the FDA granted accelerated approval to Scemblix for adult patients with Ph+ CML-CP, previously treated with two or more TKIs based on MMR rate at 24 weeks, and full approval for adult patients with Ph+ CML-CP with the T315I mutation. Novartis has also shared the longer-term, 96-week efficacy and safety data with the FDA, which is currently under evaluation through a priority review.
Scemblix is being studied across multiple treatment lines for CML-CP, both as a monotherapy and in combination.
Shares of Novartis have lost 6% this year compared with the industry’s decline of 2.6%.
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The approval will strengthen NVS’ strong oncology portfolio. Further, the approval of new drugs bodes well for Novartis, which is looking to strengthen its core pharma business after announcing plans to spin off Sandoz, its generics and biosimilars division, into a new publicly traded standalone company last week.
In October 2021, Novartis announced the commencement of a strategic review of the Sandoz division. This was because industry-wide price competition among generic pharmaceutical companies and consolidation of buyers caused significant declines in sales and profits of Sandoz, particularly in the United States.
Earlier, the company had spun off its eye care division, Alcon, into a new company.
Novartis will focus on further strengthening its position in five core therapeutic areas (Hematology, Solid Tumors, Immunology, Neuroscience and Cardiovascular) and technology platforms (Gene Therapy, Cell Therapy, Radioligand Therapy, Targeted Protein Degradation and xRNA), and achieving a balanced geographic footprint.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in this space are Bolt Pharmaceuticals BOLT, Acadia Pharmaceuticals ACAD and Dynavax DVAX. All three carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
Loss estimates for ACAD have narrowed to $1.30 from $1.40 in the past 60 days. ACAD surpassed earnings in two of the trailing four quarters, the average being 6.83%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax surpassed estimates in two of the trailing four quarters.
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