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Merck's (MRK) Keytruda Gets Full Approval for Bladder Cancer
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Merck & Co., Inc. (MRK - Free Report) announced that the FDA has approved to convert an accelerated approval to a full (regular) approval for its blockbuster cancer drug Keytruda as a first-line treatment for advanced urothelial carcinoma (bladder cancer).
Along with this conversion, the FDA also revised the label of the drug to include patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy. Previously, the drug was also indicated for locally advanced or mUC patients who were not eligible for cisplatin-containing chemotherapy and whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10) or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
The accelerated approval was based on KEYNOTE-052 study with the final approval contingent on data from the KEYNOTE-361 study.
Earlier this year, Merck reported dismal data from the KEYNOTE-361 study —The study failed to meet its dual primary endpoints — overall survival or progression-free survival — and failed to show statistically significant improvement compared to standard-of-care chemotherapy in the patient population.
Although the KEYNOTE-361 study failed to meet its co-primary endpoints, the FDA’s Oncologic Drugs Advisory Committee (ODAC) meeting, earlier this year, voted in favor of maintaining the accelerated approval of Keytruda for its first-line bladder indication
Apart from first-line bladder cancer, Keytruda is also approved to treat locally advanced or mUC in patients whose disease has progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The drug is also approved as a treatment for Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer.
Merck’s stock has declined 6.8% this year so far against an increase of 16.2% for the industry.
Image Source: Zacks Investment Research
Keytruda is a key top-line driver for Merck as it is approved for the treatment of many cancers globally. The drug generated sales of $4.18 billion in the second quarter of 2021, up 20% (excluding Fx impact) year over year.
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 more than 30 types of cancer in more than 1550 studies, including more than 1100 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.
Undoubtedly, Keytruda has strong growth prospects based on increased utilization, approval for new indications and expectation of additional approvals worldwide. Though Keytruda may be Merck’s biggest strength and a solid reason to own the stock, it can also be argued that the company is excessively dependent on the drug and should look for ways to diversify its product lineup.
Image: Shutterstock
Merck's (MRK) Keytruda Gets Full Approval for Bladder Cancer
Merck & Co., Inc. (MRK - Free Report) announced that the FDA has approved to convert an accelerated approval to a full (regular) approval for its blockbuster cancer drug Keytruda as a first-line treatment for advanced urothelial carcinoma (bladder cancer).
Along with this conversion, the FDA also revised the label of the drug to include patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy. Previously, the drug was also indicated for locally advanced or mUC patients who were not eligible for cisplatin-containing chemotherapy and whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10) or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
The accelerated approval was based on KEYNOTE-052 study with the final approval contingent on data from the KEYNOTE-361 study.
Earlier this year, Merck reported dismal data from the KEYNOTE-361 study —The study failed to meet its dual primary endpoints — overall survival or progression-free survival — and failed to show statistically significant improvement compared to standard-of-care chemotherapy in the patient population.
Although the KEYNOTE-361 study failed to meet its co-primary endpoints, the FDA’s Oncologic Drugs Advisory Committee (ODAC) meeting, earlier this year, voted in favor of maintaining the accelerated approval of Keytruda for its first-line bladder indication
Apart from first-line bladder cancer, Keytruda is also approved to treat locally advanced or mUC in patients whose disease has progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The drug is also approved as a treatment for Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer.
Merck’s stock has declined 6.8% this year so far against an increase of 16.2% for the industry.
Image Source: Zacks Investment Research
Keytruda is a key top-line driver for Merck as it is approved for the treatment of many cancers globally. The drug generated sales of $4.18 billion in the second quarter of 2021, up 20% (excluding Fx impact) year over year.
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 more than 30 types of cancer in more than 1550 studies, including more than 1100 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.
Undoubtedly, Keytruda has strong growth prospects based on increased utilization, approval for new indications and expectation of additional approvals worldwide. Though Keytruda may be Merck’s biggest strength and a solid reason to own the stock, it can also be argued that the company is excessively dependent on the drug and should look for ways to diversify its product lineup.
Merck & Co., Inc. Price
Merck & Co., Inc. price | Merck & Co., Inc. Quote
Zacks Rank
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.