Novartis NVS announced that the European Commission (“EC”) has approved its breast cancer drug Kisqali (ribociclib) for a broad population.

The EC has approved Kisqali in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence.

Kisqali is a selective cyclin-dependent kinase inhibitor, a class of drugs that helps slow the progression of cancer by inhibiting two proteins — cyclin-dependent kinase 4 and 6 (CDK4/6).

The latest approval will make twice as many EBC patients in Europe, including those with node-negative disease, eligible for treatment with Kisqali to help reduce their risk of recurrence.

Year to date, shares of Novartis have risen 3.9% compared with the industry’s growth of 8%.

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Broader Label for NVS’ Kisqali

The EC approval is based on results from the late-stage NATALEE study in a broad patient population with HR+/HER2- stage II and III EBC, including those with node-negative disease.

The results showed a significant and clinically meaningful 25.1% reduction in risk of disease recurrence with adjuvant Kisqali plus endocrine therapy (ET) compared to ET alone. The invasive disease-free survival (iDFS) benefit was consistently observed across all patient subgroups.

Please note that Kisqali is already approved for the treatment of metastatic breast cancer (MBC) in several countries.

The EC approval followed the recent FDA approval of Kisqali for EBC patients and the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology’s recommendation as a Category 1 preferred breast cancer adjuvant treatment.

Novartis will continue to evaluate NATALEE patients for long-term outcomes, including overall survival.

Kisqali: A Top Drug for NVS

Kisqali is one of the key growth drivers for NVS, which is now a pure-play innovative medicine company with a focus on core therapeutic areas — cardiovascular, renal and metabolic, immunology, neuroscience and oncology. It is one of the leading breast cancer drugs in the United States and outside the country, with a dominant market share. The drug generated sales worth $2.1 billion in the first nine months of 2024.

Breast cancer is the most commonly diagnosed cancer in Europe. Per estimates, approximately 70% of cases are diagnosed in the early stages of the disease. Also, for many patients diagnosed with stage II or III HR+/HER2- EBC, the risk of recurrence is high even after many years, despite treatment with endocrine therapy.

Hence, the approval of Kisqali for a broader label increases the sales potential of the drug.

Last year, the FDA also expanded the indication for Eli Lilly’s LLY Verzenio’s (abemaciclib). Verzenio, a CDK4/6 inhibitor, was approved in combination with ET for the adjuvant treatment of HR+HER2-, node-positive, EBC at a high risk of recurrence.

Eli Lilly has witnessed a stupendous run in 2024, riding high on the success of its GLP-1 drugs — Mounjaro and Zepbound.

NVS’ Zacks Rank & Stock to Consider

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

A better-ranked stock from the large-cap pharma industry is Pfizer PFE, which currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.85 to $2.92. PFE’s shares have lost 10.3% year to date.

Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.

 

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