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Novartis (NVS) Oncology Drug Gets FDA Nod for Label Expansion

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Novartis (NVS - Free Report) announced that the FDA granted approval to the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) for another indication.

The combination has now been approved for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

LGG is the most common pediatric brain cancer and BRAF V600 mutations are present in 15-20% of these cases.

This FDA approval is the sixth for this combination, which is indicated across multiple BRAF V600 solid tumors, including melanoma, thyroid cancer and lung cancer.

The FDA also approved liquid formulations of Tafinlar and Mekinist, marking the first time a BRAF/MEK inhibitor has been developed in a formulation suitable for patients as young as one year of age.

These approvals make the combination the first and only approved combination targeted therapy to treat pediatric patients with BRAF V600E LGG.

This FDA is based on results from the phase II/III TADPOLE trial (NCT02684058) that showed patients randomized to receive Tafinlar + Mekinist experienced a statistically significant improvement in the overall response rate (ORR) of 47% compared to 11% for those randomized to receive chemotherapy. The median progression-free survival (PFS) was 20.1 months with Tafinlar + Mekinist compared to 7.4 months with chemotherapy at a median follow-up of 18.9 months.

Tafinlar + Mekinist generated sales of $1.8 billion in 2022, up 5% from 2021.
Shares of Novartis have lost 4.7% in the past year against the industry’s growth of 0.8%.

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Novartis’ performance in the fourth quarter was mixed, as earnings beat estimates but revenues lagged due to generic competition for Gilenya and a decline in Cosentyx sales. With the planned spin-off of Sandoz, Novartis is looking to become a pure-play pharmaceutical company. Drugs like Entresto, Kesimpta, Zolgensma, Kisqali and Leqvio should continue to fuel growth and offset the impact of generic competition. Pluvicto and Scemblix saw impactful launches and the Leqvio launch continues to progress.

Novartis expects net sales for 2023 to grow in the low- to mid-single digits.
Novartis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector are Novo Nordisk (NVO - Free Report) and Ligand Therapeutics (LGND - Free Report) , both carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43 and estimates for 2024 have gone up by 29 cents to $5.19.

Ligand’s earnings per share estimates for 2023 increased to $4.32 from $3.30 in the past 30 days. LGND beat earnings estimates in one of the last four reported quarters.


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