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Merck's (MRK) VHL-Linked Tumor Drug Welireg Gets FDA Nod
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Merck & Co., Inc. (MRK - Free Report) announced that the FDA has granted approval to its novel HIF-2α inhibitor belzutifan (120 mg once daily) to treat some von Hippel-Lindau (VHL) disease-associated tumors. The drug, to be marketed by the trade name of Welireg, is approved for the treatment of patients with VHL-associated renal cell carcinoma (RCC) central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), in patients who do not require immediate surgery. The drug’s FDA approval came a month earlier than the PDUFA date of Sep 15, 2021.
Merck’s stock has declined 6.2% this year so far against an increase of 17.3% for the industry.
Image Source: Zacks Investment Research
The approval was based on data from a phase II study on the candidate in patients with VHL-associated tumors. Data from the study showed that treatment with Welireg led to a reduction in tumor size (objective response rate) in 49% of the patients with VHL disease-associated RCC and 63% and 83% of patients with VHL-associated CNS hemangioblastomas or pNET, respectively. The approval of this first FDA approved HIF-2α inhibitor comes with a boxed warning on the label, which states that exposure to this drug at the time of pregnancy can result in embryo-fetal harm.
Per the company, VHL disease is a rare genetic condition for which currently there is no systemic treatment option available. Patients with VHL are at the risk of developing benign blood vessel tumors and sometimes also cancerous tumors including RCC.
Welireg was a part of Merck’s lucrative oncology pipeline. In its oncology portfolio, Merck’s blockbuster PD-L1 inhibitor, Keytruda is being studied for more than 30 types of cancer in more than 1550 studies, including more than 1100 combination studies. Keytruda is already marketed for several cancers globally. Merck has collaborated with several companies including Amgen (AMGN - Free Report) , Glaxo (GSK - Free Report) and Pfizer separately for the evaluation of Keytruda in combination with other regimens. Its PARP inhibitor drug, Lynparza, which it markets in partnership with AstraZeneca (AZN - Free Report) , is also being evaluated in combination with Keytruda for colorectal cancer, non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Lenvima, in partnership with Japan’s Eisai, is being studied in combination with Keytruda for bladder, colorectal gastric, head and neck squamous cell carcinoma, gastric, melanoma and NSCLC cancers
Image: Bigstock
Merck's (MRK) VHL-Linked Tumor Drug Welireg Gets FDA Nod
Merck & Co., Inc. (MRK - Free Report) announced that the FDA has granted approval to its novel HIF-2α inhibitor belzutifan (120 mg once daily) to treat some von Hippel-Lindau (VHL) disease-associated tumors. The drug, to be marketed by the trade name of Welireg, is approved for the treatment of patients with VHL-associated renal cell carcinoma (RCC) central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), in patients who do not require immediate surgery. The drug’s FDA approval came a month earlier than the PDUFA date of Sep 15, 2021.
Merck’s stock has declined 6.2% this year so far against an increase of 17.3% for the industry.
Image Source: Zacks Investment Research
The approval was based on data from a phase II study on the candidate in patients with VHL-associated tumors. Data from the study showed that treatment with Welireg led to a reduction in tumor size (objective response rate) in 49% of the patients with VHL disease-associated RCC and 63% and 83% of patients with VHL-associated CNS hemangioblastomas or pNET, respectively. The approval of this first FDA approved HIF-2α inhibitor comes with a boxed warning on the label, which states that exposure to this drug at the time of pregnancy can result in embryo-fetal harm.
Per the company, VHL disease is a rare genetic condition for which currently there is no systemic treatment option available. Patients with VHL are at the risk of developing benign blood vessel tumors and sometimes also cancerous tumors including RCC.
Welireg was a part of Merck’s lucrative oncology pipeline. In its oncology portfolio, Merck’s blockbuster PD-L1 inhibitor, Keytruda is being studied for more than 30 types of cancer in more than 1550 studies, including more than 1100 combination studies. Keytruda is already marketed for several cancers globally. Merck has collaborated with several companies including Amgen (AMGN - Free Report) , Glaxo (GSK - Free Report) and Pfizer separately for the evaluation of Keytruda in combination with other regimens. Its PARP inhibitor drug, Lynparza, which it markets in partnership with AstraZeneca (AZN - Free Report) , is also being evaluated in combination with Keytruda for colorectal cancer, non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Lenvima, in partnership with Japan’s Eisai, is being studied in combination with Keytruda for bladder, colorectal gastric, head and neck squamous cell carcinoma, gastric, melanoma and NSCLC cancers
Merck currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.