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Merck's (MRK) Keytruda Gets Four New Approvals in Japan

Merck & Co., Inc. MRK announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved its blockbuster anti-PD-1 therapy, Keytruda (pembrolizumab), for four new cancer indications in the country.

The MHLW has now approved Keytruda in combination with chemotherapy as neoadjuvant treatment and then continued as a monotherapy as adjuvant treatment following surgery in patients with HER2-negative breast cancer, who are at high risk of disease recurrence.

The MHLW also approved Keytruda in combination with chemotherapy, with or without bevacizumab, for the treatment of advanced or recurrent cervical cancer in patients with no prior chemotherapy, who are not amenable to curative treatment.

Keytruda as monotherapy is now approved in Japan for the adjuvant treatment of renal cell carcinoma in certain patients who are at increased risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.

The MHLW has also approved Keytruda as a monotherapy for the adjuvant treatment of patients with stage IIB or IIC melanoma after complete resection.

Following these latest approvals by the MHLW, Keytruda now has 23 approved uses across 13 different types of cancer indications in Japan.

Shares of Merck have rallied 12% so far this year against the industry’s decline of 6.9%.

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Keytruda is already approved for the treatment of several types of cancer indications globally. The drug accounts for around 40% of Merck’s pharmaceutical sales.

Keytruda has played an instrumental role in driving Merck’s revenue growth in the past few years. The drug is continuously growing and expanding into new indications and markets globally.

The Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 1750 studies, including nearly 1300 combination studies. Meanwhile, Keytruda is being studied in phase III studies for biliary tract, gastric, hepatocellular, cutaneous squamous cell, mesothelioma, ovarian, and prostate cancers, among others.

Zacks Rank & Stocks to Consider

Merck currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Aptose Biosciences Inc. APTO, Atara Biotherapeutics, Inc. ATRA and ORIC Pharmaceuticals, Inc. ORIC, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aptose Biosciences’ loss per share estimates narrowed by 15.7% for 2022 and 15% for 2023 in the past 60 days.

Earnings of Aptose Biosciences surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. APTO delivered an earnings surprise of 2.23%, on average.

Atara Biotherapeutics’ loss per share estimates narrowed 43.2% for 2022 and 21.3% for 2023 in the past 60 days.

Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.

ORIC Pharmaceuticals’ loss per share estimates narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.

Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.


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