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Merck's (MRK) Keytruda Gets FDA Nod for Expanded Melanoma Use

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Merck (MRK - Free Report) announced that its blockbuster drug Keytruda (pembrolizumab) has received approval for adjuvant treatment of adult and pediatric patients (aged 12 years and above) with stage IIB or IIC melanoma following complete resection.

The FDA has also granted approval to Keytruda as an adjuvant treatment for pediatric patients (aged 12 years and above) with stage III melanoma following complete resection. Please note that Keytruda is already approved as an adjuvant treatment for adult patients with stage III melanoma following complete resection.

The approval for Keytruda in stage IIB and IIC melanoma is based on data from phase III KEYNOTE-716 study that evaluated Keytruda in combination with placebo for upto one year in patients with completely resected stage IIB or IIC melanoma. In the study, Keytruda demonstrated a statistically significant improvement in recurrence-free survival, thereby reducing the risk of disease recurrence or death by 35% compared to placebo.

Merck’s stock has declined 10.3% this year so far against the industry’s 12.4% rise.

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Melanoma, which is the most serious form of skin cancer, is marked by the uncontrolled growth of pigment-producing cells.

During third-quarter 2021, Merck recorded $4.5 billion in sales from Keytruda. Keytruda is already approved for the treatment of many cancers globally. Sales of the drug are gaining from continued uptake in various cancer indications. Development of the drug in other indications is also progressing well. In fact, Keytruda is being studied across a wide variety of cancers and treatment settings in more than 1600 studies, including combination studies. Label expansions for new cancer indications, if approved, can further boost sales.

Zacks Rank & Stocks to Consider

Merck currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the drug/biotech sector include Endo International (ENDP - Free Report) , GlaxoSmithKline (GSK - Free Report) and Precision BioSciences (DTIL - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Endo International’s earnings per share estimates for 2021 have increased from $2.32 to $2.84 in the past 30 days. The same for 2022 has increased from $2.25 to $2.47 in the past 30 days.

Earnings of Endo International beat estimates in all the last four quarters, with the average being 57.7%.

GlaxoSmithKline’s earnings per share estimates for 2021 have increased from $3.02 to $3.06 in the past 30 days. The same for 2022 has increased from $3.23 to $3.26 in the past 30 days. Shares of Glaxo have risen 12.1% in the year so far.

Earnings of GlaxoSmithKline beat estimates in three of the last four quarters and missed once, with the average surprise being 15.3%.

Precision BioSciences’ loss per share estimates for 2021 have narrowed from $1.17 to $0.65 in the past 30 days. The same for 2022 has narrowed from $2.39 to $1.91 in the past 30 days.

Earnings of Precision BioSciences beat estimates in all the last four quarters, delivering a surprise of 76.9%, on average.

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