Merck's Keytruda Obtains its First FDA Approval for Mesothelioma
Merck & Co., Inc. MRK announced that the FDA had approved its blockbuster anti-PD-1 therapy, Keytruda (pembrolizumab), for a new indication.
The regulatory body has now approved Keytruda in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Pleural mesothelioma is a type of cancer which develops in the tissue that lines the lungs or pleura.
This is the first time Keytruda has been approved for the given indication in the United States.
Shares of Merck have risen 8.8% so far this year compared with the industry’s growth of 24.1%.
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Approval Based on MRK's Pivotal KEYNOTE-483 Study
The latest approval for Keytruda in first-line MPM was based on data from the pivotal phase II/III KEYNOTE-483 study.
Data from the study showed that treatment with Keytruda plus chemotherapy led to a statistically significant improvement in overall survival (OS), reducing the risk of death by 21% versus chemotherapy alone.
Treatment with Keytruda plus chemotherapy resulted in a median OS of 17.3 months compared to 16.1 months for chemotherapy alone.
Keytruda plus chemotherapy also significantly improved progression-free survival versus chemotherapy alone, while the overall response rate was significantly higher in the Keytruda plus chemotherapy as compared with chemotherapy alone.
Keytruda - MRK's Biggest Revenue Driver
Keytruda is already approved for the treatment of many cancers globally and accounts for around 50% of Merck’s pharmaceutical sales.
This is one of the most successful cancer drugs ever and is considered a market leader for treating non-small cell lung cancer.
Keytruda is approved for 40 distinct cancer indications. Sales of the drug are gaining from rapid uptake across earlier-stage indications as well as continued strong momentum in metastatic indications. The drug has played an instrumental role in driving Merck’s steady revenue growth in the past few years. Keytruda sales continue to grow year over year as well as sequentially. The drug generated sales of more than $14 billion in the first half of 2024.
Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Illumina, Inc. ILMN, Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, each sporting 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 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.84 to $3.62. Earnings per share estimates for 2025 have improved from $3.22 to $4.43. Year to date, shares of ILMN have lost 5.9%.
ILMN’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $2.09 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 47.3%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 33 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 49%.
FULC’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.
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