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Merck's Keytruda Gets Priority Review for Hodgkin Lymphoma
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Another Merck & Co., Inc.’s (MRK - Free Report) supplemental Biologics License Application (sBLA) – the second this week – for its anti-PD-1 therapy, Keytruda, has been accepted for priority review by the FDA.
This time, the company is looking to expand the label for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or who had relapsed after three or more prior lines of therapy.
Merck’s shares are up 15% this year comparing favorably with a decline of 8.1% for 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 story, with the FDA granting priority review, a response should be out by Mar 15, 2017. In April, the FDA granted Breakthrough Therapy designation to the drug for the indication. The sNDA submission was based on positive data from KEYNOTE-087 and KEYNOTE-013 trials. The sBLA, which is seeking approval for a fixed dose of 200 mg of Keytruda given intravenously every three weeks, will be reviewed under the FDA’s Accelerated Approval program. This is the first time that Merck is seeking approval for hematologic malignancy.
Earlier this week, a sBLA from Merck to expand the label of Keytruda for the treatment of previously treated patients with advanced microsatellite instability-high (MSI-H) cancer was accepted for priority review by the FDA, also on an accelerated approval basis. (PDUFA date: Mar 8, 2017)
Keytruda is currently approved in the U.S. for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. It is also approved for the first-line treatment of patients with unresectable or metastatic melanoma in patients refractory to Yervoy.
It is also approved for the treatment of metastatic lung cancer (NSCLC) in patients whose tumors express PD-L1 as determined by an FDA-approved test and whose disease progressed on or after platinum-containing chemotherapy. In October, Keytruda received an earlier-than-expected FDA approval for the first-line treatment of metastatic lung cancer. This is an important milestone for the company and Keytruda sales should improve sharply with the first-line NSCLC indication. Additionally, in August, Keytruda was approved for previously treated recurrent or metastatic head and neck cancer (HNSCC).
New products like Keytruda have been contributing meaningfully to Merck’s top line, somewhat making up for the generic competition for several drugs. Keytruda is the first anti-PD-1 therapy to gain FDA approval and is being studied for more than 30 types of cancer. Merck is collaborating with several companies including Amgen, Inc. (AMGN - Free Report) , Incyte, GlaxoSmithKline plc (GSK - Free Report) and Pfizer Inc. (PFE - Free Report) among others separately for the evaluation of Keytruda in combination with other regimens. The last few months have seen a series of positive news regarding Keytruda, raising sales expectations for the drug. Further, label expansion of the key drug should significantly boost sales of Merck.
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Merck's Keytruda Gets Priority Review for Hodgkin Lymphoma
Another Merck & Co., Inc.’s (MRK - Free Report) supplemental Biologics License Application (sBLA) – the second this week – for its anti-PD-1 therapy, Keytruda, has been accepted for priority review by the FDA.
This time, the company is looking to expand the label for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or who had relapsed after three or more prior lines of therapy.
Merck’s shares are up 15% this year comparing favorably with a decline of 8.1% for the Zacks classified Large-Cap Pharma industry backed by consistently strong earnings results and regular positive news flow and regulatory updates.
MERCK & CO INC Price
MERCK & CO INC Price | MERCK & CO INC Quote
Coming back to the latest news story, with the FDA granting priority review, a response should be out by Mar 15, 2017. In April, the FDA granted Breakthrough Therapy designation to the drug for the indication. The sNDA submission was based on positive data from KEYNOTE-087 and KEYNOTE-013 trials. The sBLA, which is seeking approval for a fixed dose of 200 mg of Keytruda given intravenously every three weeks, will be reviewed under the FDA’s Accelerated Approval program. This is the first time that Merck is seeking approval for hematologic malignancy.
Earlier this week, a sBLA from Merck to expand the label of Keytruda for the treatment of previously treated patients with advanced microsatellite instability-high (MSI-H) cancer was accepted for priority review by the FDA, also on an accelerated approval basis. (PDUFA date: Mar 8, 2017)
Keytruda is currently approved in the U.S. for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. It is also approved for the first-line treatment of patients with unresectable or metastatic melanoma in patients refractory to Yervoy.
It is also approved for the treatment of metastatic lung cancer (NSCLC) in patients whose tumors express PD-L1 as determined by an FDA-approved test and whose disease progressed on or after platinum-containing chemotherapy. In October, Keytruda received an earlier-than-expected FDA approval for the first-line treatment of metastatic lung cancer. This is an important milestone for the company and Keytruda sales should improve sharply with the first-line NSCLC indication. Additionally, in August, Keytruda was approved for previously treated recurrent or metastatic head and neck cancer (HNSCC).
New products like Keytruda have been contributing meaningfully to Merck’s top line, somewhat making up for the generic competition for several drugs. Keytruda is the first anti-PD-1 therapy to gain FDA approval and is being studied for more than 30 types of cancer. Merck is collaborating with several companies including Amgen, Inc. (AMGN - Free Report) , Incyte, GlaxoSmithKline plc (GSK - Free Report) and Pfizer Inc. (PFE - Free Report) among others separately for the evaluation of Keytruda in combination with other regimens. The last few months have seen a series of positive news regarding Keytruda, raising sales expectations for the drug. Further, label expansion of the key drug should significantly boost sales of Merck.
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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In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>