Novartis NVS announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (EMA) recommended granting approval to the breast cancer drug Kisqali (ribociclib) for a broader patient population.

The CHMP adopted a positive opinion for the marketing authorization for Kisqali for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC), at high risk of disease recurrence, including those with node-negative disease.

Year to date, shares of Novartis have risen 16.1% compared with the industry’s growth of 20.6%.

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Broader Label for NVS’ Kisqali

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

The positive CHMP decision for a broad population of patients diagnosed with HR+/HER2- EBC at high risk of recurrence is based on robust data from the late-stage NATALEE study.

Data from the study showed that Kisqali plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.1% in patients with stage II and III HR+/HER2- EBC. The combination also demonstrated a consistent, clinically meaningful invasive disease-free survival (iDFS) benefit across key pre-specified subgroups.

Data from the pivotal trial also showed that Kisqali's safety profile at the 400mg dose was well-tolerated, with generally low-grade symptomatic adverse events.

Following the CHMP’s positive recommendation, the European Commission (EC) will take a final decision within approximately two months.

Breast cancer is the most commonly diagnosed cancer in Europe. HR+/HER2- is the most common subtype and accounts for approximately 70% of all breast cancers. More than 40% of these are diagnosed in stage II or III.

Per estimates, patients with stage II or III HR+/HER2- EBC face a significant risk of cancer recurrence, often as incurable metastatic disease, despite adjuvant ET and regardless of nodal involvement.

A potential approval of Kisqali will provide an effective and tolerable adjuvant treatment option for these patients, mitigating the risk of recurrence in a broader patient population, including those with high-risk node-negative disease.

Novartis added that Kisqali could nearly double the number of patients eligible for CDK4/6 inhibitor adjuvant therapy.

Please note that Kisqali was approved as a treatment for EBC by the FDA in September 2024.

The drug is approved as a treatment for metastatic breast cancer patients in several countries, including the United States and EU.

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 focused 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 $1.3 billion in the first half of 2024.

Last year, the FDA also expanded Eli Lilly’s LLY Verzenio’s (abemaciclib) indication. 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.

Sales of Verzenio totaled $2.4 billion in the first half of 2024.

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

NVS’ Zacks Rank & Another Stock to Consider

NVS currently carries a Zacks Rank #2 (Buy).

Another top-ranked company from the large-cap pharma industry is Bayer BAYRY, which currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Estimates for Bayer’s 2024 earnings per share have increased from $1.35 to $1.38 over the past 90 days, while the same for 2025 has risen from $1.42 to $1.44. Bayer’s shares have lost 23.5% year to date.    

 

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