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Merck's Keytruda Gets Priority Review for Bladder Cancer
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Merck & Co., Inc.’s (MRK - Free Report) two supplemental Biologics License Applications (sBLA) for its anti-PD-1 therapy, Keytruda, have been accepted under priority review by the FDA.
This time, the company is looking to expand the label of Keytruda for the treatment of patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer. It has filed separate applications for the first-line treatment of patients who are ineligible for cisplatin-containing therapy; and for second-line use in patients with disease progression on or after platinum-containing chemotherapy.
Presently, Keytruda is approved in the U.S. for the treatment of previously untreated metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express high levels of PD-L1 and previously treated metastatic NSCLC in patients whose tumors express PD-L1, as well as advanced melanoma, and previously treated recurrent or metastatic head and neck cancer (HNSCC).
Merck’s shares have been up 9.2% so far this year, comparing favorably with an increase of 0.1% witnessed by the Zacks classified Large-Cap Pharma industry, backed by consistently strong earnings results, and regular positive news flow and regulatory updates.
Coming back to the latest news, priority review for both the applications by the FDA should translate into a response by Jun 14, 2017.
Previously, the FDA had granted Breakthrough Therapy designation to the drug for the second-line indication. The applications are based on data from the phase II KEYNOTE-052 trial and the phase III KEYNOTE-045 trial. We remind investors that in Oct 2016, Merck announced that Keytruda hit the primary endpoint of overall survival (OS) in KEYNOTE-045 in patients with advanced bladder cancer. Moreover, based on a pre-specified interim analysis, an independent Data Monitoring Committee (DMC) had recommended early discontinuation of the study.
New products like Keytruda have been contributing meaningfully to Merck’s top line, somewhat making up for generic competition for several drugs. In the fourth quarter of 2016, for which results were announced last week, Keytruda brought in sales of $483 million, up 35.6% sequentially. Sales continued to be driven by label as well as geographical expansion.
Keytruda is the first anti-PD-1 therapy to gain FDA approval and is being studied for more than 30 types of cancer in 400 trials, half in combination with other cancer drugs. Merck is collaborating with several companies including Amgen, Inc. (AMGN - Free Report) , Incyte, GlaxoSmithKline plc (GSK - Free Report) and Pfizer Inc. (PFE - Free Report) separately for the evaluation of Keytruda in combination with other regimens. The last few months saw a series of positive news on Keytruda, raising sales expectations for the drug. Further label expansion of the drug should significantly boost Merck’s top line.
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Merck's Keytruda Gets Priority Review for Bladder Cancer
Merck & Co., Inc.’s (MRK - Free Report) two supplemental Biologics License Applications (sBLA) for its anti-PD-1 therapy, Keytruda, have been accepted under priority review by the FDA.
This time, the company is looking to expand the label of Keytruda for the treatment of patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer. It has filed separate applications for the first-line treatment of patients who are ineligible for cisplatin-containing therapy; and for second-line use in patients with disease progression on or after platinum-containing chemotherapy.
Presently, Keytruda is approved in the U.S. for the treatment of previously untreated metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express high levels of PD-L1 and previously treated metastatic NSCLC in patients whose tumors express PD-L1, as well as advanced melanoma, and previously treated recurrent or metastatic head and neck cancer (HNSCC).
Merck’s shares have been up 9.2% so far this year, comparing favorably with an increase of 0.1% witnessed by the Zacks classified Large-Cap Pharma industry, backed by consistently strong earnings results, and regular positive news flow and regulatory updates.
Coming back to the latest news, priority review for both the applications by the FDA should translate into a response by Jun 14, 2017.
Previously, the FDA had granted Breakthrough Therapy designation to the drug for the second-line indication. The applications are based on data from the phase II KEYNOTE-052 trial and the phase III KEYNOTE-045 trial. We remind investors that in Oct 2016, Merck announced that Keytruda hit the primary endpoint of overall survival (OS) in KEYNOTE-045 in patients with advanced bladder cancer. Moreover, based on a pre-specified interim analysis, an independent Data Monitoring Committee (DMC) had recommended early discontinuation of the study.
New products like Keytruda have been contributing meaningfully to Merck’s top line, somewhat making up for generic competition for several drugs. In the fourth quarter of 2016, for which results were announced last week, Keytruda brought in sales of $483 million, up 35.6% sequentially. Sales continued to be driven by label as well as geographical expansion.
Keytruda is the first anti-PD-1 therapy to gain FDA approval and is being studied for more than 30 types of cancer in 400 trials, half in combination with other cancer drugs. Merck is collaborating with several companies including Amgen, Inc. (AMGN - Free Report) , Incyte, GlaxoSmithKline plc (GSK - Free Report) and Pfizer Inc. (PFE - Free Report) separately for the evaluation of Keytruda in combination with other regimens. The last few months saw a series of positive news on Keytruda, raising sales expectations for the drug. Further label expansion of the drug should significantly boost Merck’s top line.
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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