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AstraZeneca (AZN) Enhertu sBLA Receives FDA Priority Tag
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AstraZeneca (AZN - Free Report) announced that the FDA has accepted and granted priority review to its and Japan-based partner, Daiichi Sankyo’s supplemental biologics license application (sBLA) seeking approval for cancer drug Enhertu for expanded use in breast cancer.
The sBLA seeks approval of Enhertu for unresectable and/or metastatic HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen. With the FDA granting priority review to the sBLA, a decision is expected during the second quarter of 2022. A similar application is also under review in Europe.
In September last year, the FDA had granted a Breakthrough Therapy Designation to Enhertu for the same indication for which the sBLA is filed.
The sBLA is based on data from the head-to-head DESTINY-Breast03 phase III study. In the study, Enhertu reduced the risk of disease progression or death by 72% compared to Roche’s (RHHBY - Free Report) Kadcyla (trastuzumab) and a taxane in patients with unresectable and/or metastatic HER2-positive metastatic breast cancer previously treated with Kadcyla and a taxane.
Roche’s Kadcyla, also a HER2-directed antibody drug conjugate (ADC) like Enhertu, is the current standard of treatment for previously treated HER2-positive metastatic breast cancer.
The sBLA is being evaluated under FDA’s Real-Time Oncology Review and Project Orbis programs. Both the programs are FDA’s initiatives to quickly bring effective cancer treatments for patients.
Please note that Enhertu is already approved to treat unresectable or metastatic HER2-positive breast cancer in patients who have received two or more prior anti-HER2-based regimens in the metastatic setting based on data from the DESTINY-Breast01 study.
In the past year, AstraZeneca’s shares have risen 14.9% compared with an increase of 16.9% for the industry.
Image Source: Zacks Investment Research
AstraZeneca had acquired joint development and commercialization rights to Enhertu from Japan’s Daiichi Sankyo in April 2019. Sales of Enhertu in the United States are recognized by Daiichi Sankyo while AstraZeneca records its share of profit from the sales of the drug in the United States as collaboration revenues.
Enhertu was approved for its second indication, HER2+, metastatic gastric cancer in January 2021. It is also being evaluated for other HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.
Enhertu is part of AstraZeneca’s flourishing oncology portfolio. Other key oncology drugs in AstraZeneca’s portfolio are Imfinzi, Tagrisso and Lynparza. AstraZeneca markets Lynparza in partnership with Merck (MRK - Free Report) .
AstraZeneca & Merck’s Lynparza is approved for four cancer types — ovarian, breast, prostate and pancreatic. Lynparza is also being evaluated in an earlier-line setting for the approved cancer indications as well some other cancer types
AstraZeneca currently carries a Zacks Rank #4 (Sell).
A better-ranked large drugmaker is Pfizer (PFE - Free Report) , which has a Zacks Rank of 1.
Pfizer’s stock has risen 55.5% in the past year. Estimates for Pfizer’s 2022 earnings have gone up from $3.86 to $5.80 over the past 60 days.
Pfizer’s earnings performance has been mixed, with the company exceeding earnings expectations in three of the last four quarters while missing in one. PFE has a four-quarter earnings surprise of 10.85%, on average.
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AstraZeneca (AZN) Enhertu sBLA Receives FDA Priority Tag
AstraZeneca (AZN - Free Report) announced that the FDA has accepted and granted priority review to its and Japan-based partner, Daiichi Sankyo’s supplemental biologics license application (sBLA) seeking approval for cancer drug Enhertu for expanded use in breast cancer.
The sBLA seeks approval of Enhertu for unresectable and/or metastatic HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen. With the FDA granting priority review to the sBLA, a decision is expected during the second quarter of 2022. A similar application is also under review in Europe.
In September last year, the FDA had granted a Breakthrough Therapy Designation to Enhertu for the same indication for which the sBLA is filed.
The sBLA is based on data from the head-to-head DESTINY-Breast03 phase III study. In the study, Enhertu reduced the risk of disease progression or death by 72% compared to Roche’s (RHHBY - Free Report) Kadcyla (trastuzumab) and a taxane in patients with unresectable and/or metastatic HER2-positive metastatic breast cancer previously treated with Kadcyla and a taxane.
Roche’s Kadcyla, also a HER2-directed antibody drug conjugate (ADC) like Enhertu, is the current standard of treatment for previously treated HER2-positive metastatic breast cancer.
The sBLA is being evaluated under FDA’s Real-Time Oncology Review and Project Orbis programs. Both the programs are FDA’s initiatives to quickly bring effective cancer treatments for patients.
Please note that Enhertu is already approved to treat unresectable or metastatic HER2-positive breast cancer in patients who have received two or more prior anti-HER2-based regimens in the metastatic setting based on data from the DESTINY-Breast01 study.
In the past year, AstraZeneca’s shares have risen 14.9% compared with an increase of 16.9% for the industry.
AstraZeneca had acquired joint development and commercialization rights to Enhertu from Japan’s Daiichi Sankyo in April 2019. Sales of Enhertu in the United States are recognized by Daiichi Sankyo while AstraZeneca records its share of profit from the sales of the drug in the United States as collaboration revenues.
Enhertu was approved for its second indication, HER2+, metastatic gastric cancer in January 2021. It is also being evaluated for other HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.
Enhertu is part of AstraZeneca’s flourishing oncology portfolio. Other key oncology drugs in AstraZeneca’s portfolio are Imfinzi, Tagrisso and Lynparza. AstraZeneca markets Lynparza in partnership with Merck (MRK - Free Report) .
AstraZeneca & Merck’s Lynparza is approved for four cancer types — ovarian, breast, prostate and pancreatic. Lynparza is also being evaluated in an earlier-line setting for the approved cancer indications as well some other cancer types
AstraZeneca currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stock to Consider
A better-ranked large drugmaker is Pfizer (PFE - Free Report) , which has a Zacks Rank of 1.
Pfizer’s stock has risen 55.5% in the past year. Estimates for Pfizer’s 2022 earnings have gone up from $3.86 to $5.80 over the past 60 days.
Pfizer’s earnings performance has been mixed, with the company exceeding earnings expectations in three of the last four quarters while missing in one. PFE has a four-quarter earnings surprise of 10.85%, on average.