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Pfizer (PFE) Lorbrena First-Line sNDA Gets FDA Priority Review
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Pfizer Inc. (PFE - Free Report) announced that the FDA has accepted the supplemental new drug application (sNDA) for its tyrosine kinase inhibitor cancer drug, Lorbrena (lorlatinib), and granted priority review to the application. The sNDA is seeking label expansion of Lorbrena as a first-line treatment for ALK-positive metastatic non-small cell lung cancer (NSCLC). A decision from the FDA is expected by April 2021.
The sNDA was supported by data from the phase III CROWN study, evaluating the drug in previously untreated advanced ALK-positive NSCLC patients. Data from the study showed that treatment with Lorbrena improved progression free survival in patients compared to Pfizer’s another NSCLC drug, Xalkori (crizotinib).
Please note that Lorbrena is already approved for treating ALK-positive metastatic NSCLC in previously-treated patients under accelerated pathway. The drug is available for patients who have been previously treated with Xalkori and at least one other ALK inhibitor or whose disease has progressed following treatment with Roche’s (RHHBY - Free Report) Alecensa (alectinib) or Novartis’ (NVS - Free Report) Zykadia (ceritinib) as the first ALK inhibitor therapy. The CROWN study data will also support a full approval for the drug in this treatment setting.
The FDA informed that the sNDA is being reviewed under its Real-Time Oncology Review (RTOR) pilot program and will also be reviewed under Project ORBIS. The RTOR program is intended to create a more efficient review process to bring safe and effective treatments to people as early as possible. A review under Project ORBIS will help support potential concurrent submissions and collaborative review with health authorities in Canada, Singapore, Switzerland, Australia, Brazil and the United Kingdom.
In the first nine months of 2020. Lorbrena recorded sales of $142 million, up almost 85% year over year.
Pfizer’s stock is down 6% this year so far against 1% increase for the industry.
Meanwhile, Pfizer and its partner BioNTech (BNTX - Free Report) are progressing well with emergency approvals and supply agreements for their coronavirus vaccine, BNT162b, in several countries of the world. The vaccine is now approved for emergency/temporary/conditional use in more than 40 countries including the United States, 27 EU member countries, United Kingdom and Canada. Last week, the U.S. government ordered 100 million additional doses of the vaccine, bringing total doses for the United States to 200 million.
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.4% per year.
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Pfizer (PFE) Lorbrena First-Line sNDA Gets FDA Priority Review
Pfizer Inc. (PFE - Free Report) announced that the FDA has accepted the supplemental new drug application (sNDA) for its tyrosine kinase inhibitor cancer drug, Lorbrena (lorlatinib), and granted priority review to the application. The sNDA is seeking label expansion of Lorbrena as a first-line treatment for ALK-positive metastatic non-small cell lung cancer (NSCLC). A decision from the FDA is expected by April 2021.
The sNDA was supported by data from the phase III CROWN study, evaluating the drug in previously untreated advanced ALK-positive NSCLC patients. Data from the study showed that treatment with Lorbrena improved progression free survival in patients compared to Pfizer’s another NSCLC drug, Xalkori (crizotinib).
Please note that Lorbrena is already approved for treating ALK-positive metastatic NSCLC in previously-treated patients under accelerated pathway. The drug is available for patients who have been previously treated with Xalkori and at least one other ALK inhibitor or whose disease has progressed following treatment with Roche’s (RHHBY - Free Report) Alecensa (alectinib) or Novartis’ (NVS - Free Report) Zykadia (ceritinib) as the first ALK inhibitor therapy. The CROWN study data will also support a full approval for the drug in this treatment setting.
The FDA informed that the sNDA is being reviewed under its Real-Time Oncology Review (RTOR) pilot program and will also be reviewed under Project ORBIS. The RTOR program is intended to create a more efficient review process to bring safe and effective treatments to people as early as possible. A review under Project ORBIS will help support potential concurrent submissions and collaborative review with health authorities in Canada, Singapore, Switzerland, Australia, Brazil and the United Kingdom.
In the first nine months of 2020. Lorbrena recorded sales of $142 million, up almost 85% year over year.
Pfizer’s stock is down 6% this year so far against 1% increase for the industry.
Meanwhile, Pfizer and its partner BioNTech (BNTX - Free Report) are progressing well with emergency approvals and supply agreements for their coronavirus vaccine, BNT162b, in several countries of the world. The vaccine is now approved for emergency/temporary/conditional use in more than 40 countries including the United States, 27 EU member countries, United Kingdom and Canada. Last week, the U.S. government ordered 100 million additional doses of the vaccine, bringing total doses for the United States to 200 million.
Pfizer Inc. Price
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Pfizer currently has 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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