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Merck Keytruda Gets FDA Approval for First-Line Lung Cancer
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Merck & Co., Inc. (MRK - Free Report) announced that the FDA has approved a label expansion of its PD-1 therapy, Keytruda, to include the first-line treatment of patients whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations.
Keytruda is approved for the treatment of metastatic NSCLC patients whose tumors express PD-L1 as determined by an FDA-approved test and whose disease has progressed on or after platinum-containing chemotherapy. However, with the latest approval, Keytruda will become the first treatment option instead of chemotherapy for such patients.
Keytruda is also approved in the U.S. for the treatment of unresectable or metastatic melanoma and disease progression, following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. Moreover, it is approved for the first-line treatment of unresectable or metastatic melanoma advanced melanoma in patients refractory to Yervoy. Further, the drug is approved for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), with disease progression on or after platinum-containing chemotherapy.
The latest approval was based on positive data from pivotal phase III KEYNOTE-024 study, which showed that Keytruda led to a significant improvement in survival in patients with high PD-L1 expression compared to chemotherapy. The drug is also under review in the EU for the same indication.
In addition, the FDA approved a label update to include data from KEYNOTE-010 study on Keytruda for the treatment of patients with metastatic NSCLC previously treated with platinum-containing chemotherapy whose tumors expressed PD-L1.
Results from KEYNOTE-010 revealed that patients treated with Keytruda demonstrated superiority in overall survival (OS) at 18 months compared to standard-of-care chemotherapy (docetaxel).
Merck is presently evaluating Keytruda for more than 30 forms of cancers including melanoma, head and neck, bladder, gastric, colorectal, esophageal, breast, ovarian, Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma and nasopharyngeal among others.
Merck is collaborating with several companies including Amgen, Inc. (AMGN - Free Report) , Incyte, GlaxoSmithKline plc (GSK - Free Report) and Pfizer Inc. (PFE - Free Report) for the evaluation of Keytruda in combination with other regimens.
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Merck Keytruda Gets FDA Approval for First-Line Lung Cancer
Merck & Co., Inc. (MRK - Free Report) announced that the FDA has approved a label expansion of its PD-1 therapy, Keytruda, to include the first-line treatment of patients whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations.
Keytruda is approved for the treatment of metastatic NSCLC patients whose tumors express PD-L1 as determined by an FDA-approved test and whose disease has progressed on or after platinum-containing chemotherapy. However, with the latest approval, Keytruda will become the first treatment option instead of chemotherapy for such patients.
Keytruda is also approved in the U.S. for the treatment of unresectable or metastatic melanoma and disease progression, following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. Moreover, it is approved for the first-line treatment of unresectable or metastatic melanoma advanced melanoma in patients refractory to Yervoy. Further, the drug is approved for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), with disease progression on or after platinum-containing chemotherapy.
The latest approval was based on positive data from pivotal phase III KEYNOTE-024 study, which showed that Keytruda led to a significant improvement in survival in patients with high PD-L1 expression compared to chemotherapy. The drug is also under review in the EU for the same indication.
In addition, the FDA approved a label update to include data from KEYNOTE-010 study on Keytruda for the treatment of patients with metastatic NSCLC previously treated with platinum-containing chemotherapy whose tumors expressed PD-L1.
Results from KEYNOTE-010 revealed that patients treated with Keytruda demonstrated superiority in overall survival (OS) at 18 months compared to standard-of-care chemotherapy (docetaxel).
Merck is presently evaluating Keytruda for more than 30 forms of cancers including melanoma, head and neck, bladder, gastric, colorectal, esophageal, breast, ovarian, Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma and nasopharyngeal among others.
Merck is collaborating with several companies including Amgen, Inc. (AMGN - Free Report) , Incyte, GlaxoSmithKline plc (GSK - Free Report) and Pfizer Inc. (PFE - Free Report) for the evaluation of Keytruda in combination with other regimens.
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Merck currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
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