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Pfizer (PFE) Lorviqua Gets EU Nod for First-Line Lung Cancer
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Pfizer (PFE - Free Report) announced that the European Commission granted its tyrosine kinase inhibitor (“TKI”) cancer drug, Lorviqua (lorlatinib) marketing authorization for expanded use. The drug will now be available as monotherapy for anaplastic lymphoma kinase ("ALK")- positive advanced non-small cell lung cancer ("NSCLC") in adults previously not treated with an ALK inhibitor.
The approval for Lorviqua as a first-line monotherapy for ALK-positive NSCLC was expected as the Committee for Medicinal Products for Human Use had recommended its authorization in December last year.
The drug was granted conditional marketing authorization in Europe in 2019 as monotherapy for ALK-positive NSCLC patients in adults whose disease had progressed following treatment with Roche’s (RHHBY - Free Report) Alecensa (alectinib) or Novartis’ (NVS - Free Report) Zykadia (ceritinib) as the first ALK TKI therapy, or Pfizer’s another lung cancer drug Xalkori (crizotinib) and at least one other ALK TKI.
The label expansion of Lorviqua as first-line monotherapy is based on data from the phase III study — CROWN — that compared efficacy and safety of Lorviqua monotherapy to Xalkori monotherapy in patients ALK-positive NSCLC. Data from the study demonstrated that Lorviqua monotherapy reduced the risk of disease progression or death by 72% versus Xalkori. Moreover, the confirmed objective response rate (secondary endpoint) was 76% in the Lorviqua-arm compared to 58% for Xalkori-treated patients.
Data from the CROWN study also demonstrated that Lorviqua treats metastases of the disease to the central nervous system better than Xalkori, suggested by improvement in intracranial complete response.
Please note that Lorviqua is available as Lorbrena in the United States and is also approved for the treatment of ALK-positive NSCLC in first-line setting.
Pfizer’s stock has risen 51.7% in the past year compared with a 17.5% increase for the industry.
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Sales of Lorbrena improved approximately 36% year over year in the first nine months of 2021 to $193 million. Its approval as a first-line treatment is likely to accelerate sales growth further.
We note that Novartis’ Zykadia is also approved for treating advanced ALK-positive NSCLC in a first-line setting since 2017. Novartis has a strong oncology portfolio, which includes Zykadia and several other popular cancer drugs. Last year, Novartis entered into an agreement with BeiGene, granting rights to market, promote and detail five approved Novartis oncology products including Zykadia, expanding the drug’s geographic reach.
Roche’s Alecensa is also approved as a first-line treatment for ALK-positive NSCLC. Roche has garnered more than $1 billion in sales from the drug in the first nine months of 2021. Roche’s lung cancer drug has shown a strong demand trend across all countries where it is available.
Roche’s Alecensa and Novartis’ Zykadia will likely be a direct competitor for Lorviqua/Lorbrena in the first-line treatment setting for ALK-positive NSCLC.
Another top-ranked pharma company is Eli Lilly (LLY - Free Report) , carrying a Zacks Rank #2 (Buy). Earnings estimates for Lilly have risen from $8.16 to $8.45 for 2022 over the past 60 days. Lilly beat earnings estimates once in the past four quarters, with the average beat being 0.54%.
Shares of Lilly have gained 20.7% in the past year.
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Pfizer (PFE) Lorviqua Gets EU Nod for First-Line Lung Cancer
Pfizer (PFE - Free Report) announced that the European Commission granted its tyrosine kinase inhibitor (“TKI”) cancer drug, Lorviqua (lorlatinib) marketing authorization for expanded use. The drug will now be available as monotherapy for anaplastic lymphoma kinase ("ALK")- positive advanced non-small cell lung cancer ("NSCLC") in adults previously not treated with an ALK inhibitor.
The approval for Lorviqua as a first-line monotherapy for ALK-positive NSCLC was expected as the Committee for Medicinal Products for Human Use had recommended its authorization in December last year.
The drug was granted conditional marketing authorization in Europe in 2019 as monotherapy for ALK-positive NSCLC patients in adults whose disease had progressed following treatment with Roche’s (RHHBY - Free Report) Alecensa (alectinib) or Novartis’ (NVS - Free Report) Zykadia (ceritinib) as the first ALK TKI therapy, or Pfizer’s another lung cancer drug Xalkori (crizotinib) and at least one other ALK TKI.
The label expansion of Lorviqua as first-line monotherapy is based on data from the phase III study — CROWN — that compared efficacy and safety of Lorviqua monotherapy to Xalkori monotherapy in patients ALK-positive NSCLC. Data from the study demonstrated that Lorviqua monotherapy reduced the risk of disease progression or death by 72% versus Xalkori. Moreover, the confirmed objective response rate (secondary endpoint) was 76% in the Lorviqua-arm compared to 58% for Xalkori-treated patients.
Data from the CROWN study also demonstrated that Lorviqua treats metastases of the disease to the central nervous system better than Xalkori, suggested by improvement in intracranial complete response.
Please note that Lorviqua is available as Lorbrena in the United States and is also approved for the treatment of ALK-positive NSCLC in first-line setting.
Pfizer’s stock has risen 51.7% in the past year compared with a 17.5% increase for the industry.
Sales of Lorbrena improved approximately 36% year over year in the first nine months of 2021 to $193 million. Its approval as a first-line treatment is likely to accelerate sales growth further.
We note that Novartis’ Zykadia is also approved for treating advanced ALK-positive NSCLC in a first-line setting since 2017. Novartis has a strong oncology portfolio, which includes Zykadia and several other popular cancer drugs. Last year, Novartis entered into an agreement with BeiGene, granting rights to market, promote and detail five approved Novartis oncology products including Zykadia, expanding the drug’s geographic reach.
Roche’s Alecensa is also approved as a first-line treatment for ALK-positive NSCLC. Roche has garnered more than $1 billion in sales from the drug in the first nine months of 2021. Roche’s lung cancer drug has shown a strong demand trend across all countries where it is available.
Roche’s Alecensa and Novartis’ Zykadia will likely be a direct competitor for Lorviqua/Lorbrena in the first-line treatment setting for ALK-positive NSCLC.
Pfizer Inc. Price
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Zacks Rank & Another Key Pick
Pfizer currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Another top-ranked pharma company is Eli Lilly (LLY - Free Report) , carrying a Zacks Rank #2 (Buy). Earnings estimates for Lilly have risen from $8.16 to $8.45 for 2022 over the past 60 days. Lilly beat earnings estimates once in the past four quarters, with the average beat being 0.54%.
Shares of Lilly have gained 20.7% in the past year.