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Novartis (NVS) Gets Positive CHMP Opinion on Lung Cancer Drug

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Novartis AG NVS announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on, and has recommended marketing authorization to Tabrecta (capmatinib). The CHMP has recommended approval of the drug as a monotherapy for the treatment of adult patients with advanced non-small-cell lung cancer (“NSCLC”) harboring alterations leading to mesenchymal-epithelial-transition factor gene (“MET”) exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

The CHMP opinion was based on data from the phase II GEOMETRY mono-1 study, which evaluated Tabrecta for the given indication. Data from the same showed that treatment with Tabrecta led to an overall response rate of 51.6% in a cohort evaluating second-line patients only and 44% in all previously-treated patients with advanced NSCLC whose tumors had alterations leading to METex14 skipping.

Per the company, in the European Union, there are an approximately 291,000 patients with locally advanced/metastatic NSCLC. METex14 skipping occurs in around 3-4% of NSCLC cases. Hence, if approved, Tabrecta may offer a new and better treatment option available for the given patient population.

Shares of Novartis have gained 2% so far this year compared with the industry’s growth of 2.7%.

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In May 2020, the FDA approved Tabrecta for the treatment of adult patients with metastatic NSCLC whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test.

Novartis had in-licensed Tabrecta from Incyte Corporation INCY in 2009. Tabrecta was discovered by Incyte.

Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib. INCY is eligible to receive royalties on net sales of Tabrecta.

Approval of new drugs and label expansion of existing drugs are likely to boost Novartis’ top line in the days to come.

The recent approvals of Piqray for advanced or metastatic breast cancer, Tabrecta for lung cancer and Pluvicto for advanced prostate cancer, further strengthened Novartis’ solid oncology portfolio.

Novartis has a strong and diverse portfolio. Solid momentum in key brands like psoriasis drug, Cosentyx; cardiovascular drug, Entresto; and gene therapy, Zolgensma, the oncology portfolio continues to boost performance.

Zacks Rank & Stocks to Consider

Novartis currently carries a Zacks Rank of #4 (Sell).

Better-ranked stocks in the healthcare sector include Eli Lilly and Company LLY and Vertex Pharmaceuticals Incorporated VRTX, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The Zacks Consensus Estimate for Eli Lilly’s earnings has been revised 2.4% upward for 2022 and 1.7% for 2023 over the past 60 days. The LLY stock has inched up 0.9% year to date.

Earnings of Eli Lilly missed estimates in each of the trailing four quarters.

Vertex’s earnings estimates have been revised 1.7% upward for 2022 and 0.4% for 2023 over the past 60 days. The VRTX stock has rallied 23.1% year to date.

Earnings of Vertex surpassed estimates in each of the trailing four quarters.


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Novartis AG (NVS) : Free Stock Analysis Report

Eli Lilly and Company (LLY) : Free Stock Analysis Report

Vertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis Report

Incyte Corporation (INCY) : Free Stock Analysis Report

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