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Merck's (MRK) Keytruda Gets FDA Nod for Advanced Skin Cancer
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Merck & Co., Inc. (MRK - Free Report) announced that the FDA has approved its blockbuster PD-1 inhibitor, Keytruda, for an expanded indication in skin cancer. The drug is now approved as a monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC), which is not curable by surgery or radiation. Notably, cSCC is the second most common form of skin cancer.
The latest FDA nod was based on second interim analysis of data from the phase II KEYNOTE-629 study. Data from the study showed that treatment with Keytruda monotherapy led to an objective response rate of 50%. The complete response rate was 17% and partial response rate was 33%.
Moreover, out of the 27 patients who responded, 81% of them had a duration of response (“DOR”) of six months or more, while 37% had a DOR of 12 months or longer.
We remind investors that in June last year, the FDA approved Keytruda for patients with recurrent or metastatic cSCC, which is not curable by surgery or radiation. Thus, Keytruda is now approved for locally advanced or recurrent, or metastatic cSCC that cannot be cured by surgery or radiation.
Merck’s shares have declined 4.5% in the year so far against the industry’s 10% increase.
Image Source: Zacks Investment Research
Keytruda, Merck’s biggest product, is already approved for treating several types of cancer across the world. The drug generated sales of $3.9 billion in the first quarter of 2021, up 16% year over year.
With continued label expansions and several ongoing label-expansion studies, the drug has a strong growth prospect. Several regulatory decisions for new indications in the United States as well as in Europe are pending, which, if approved, can further boost sales.
Keytruda is continuously growing and expanding into new indications and markets globally. In fact, the Keytruda development program is also progressing well, and the drug is being studied for over 30 types of cancer in more than 1500 studies (including more than 1050 combination studies). Merck has collaborated with several companies, including Amgen (AMGN - Free Report) , Glaxo (GSK - Free Report) and Pfizer (PFE - Free Report) , separately, for the evaluation of Keytruda in combination with other regimens.
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Image: Shutterstock
Merck's (MRK) Keytruda Gets FDA Nod for Advanced Skin Cancer
Merck & Co., Inc. (MRK - Free Report) announced that the FDA has approved its blockbuster PD-1 inhibitor, Keytruda, for an expanded indication in skin cancer. The drug is now approved as a monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC), which is not curable by surgery or radiation. Notably, cSCC is the second most common form of skin cancer.
The latest FDA nod was based on second interim analysis of data from the phase II KEYNOTE-629 study. Data from the study showed that treatment with Keytruda monotherapy led to an objective response rate of 50%. The complete response rate was 17% and partial response rate was 33%.
Moreover, out of the 27 patients who responded, 81% of them had a duration of response (“DOR”) of six months or more, while 37% had a DOR of 12 months or longer.
We remind investors that in June last year, the FDA approved Keytruda for patients with recurrent or metastatic cSCC, which is not curable by surgery or radiation. Thus, Keytruda is now approved for locally advanced or recurrent, or metastatic cSCC that cannot be cured by surgery or radiation.
Merck’s shares have declined 4.5% in the year so far against the industry’s 10% increase.
Keytruda, Merck’s biggest product, is already approved for treating several types of cancer across the world. The drug generated sales of $3.9 billion in the first quarter of 2021, up 16% year over year.
With continued label expansions and several ongoing label-expansion studies, the drug has a strong growth prospect. Several regulatory decisions for new indications in the United States as well as in Europe are pending, which, if approved, can further boost sales.
Keytruda is continuously growing and expanding into new indications and markets globally. In fact, the Keytruda development program is also progressing well, and the drug is being studied for over 30 types of cancer in more than 1500 studies (including more than 1050 combination studies). Merck has collaborated with several companies, including Amgen (AMGN - Free Report) , Glaxo (GSK - Free Report) and Pfizer (PFE - Free Report) , separately, for the evaluation of Keytruda in combination with other regimens.
Zacks Rank
Merck currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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