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AstraZeneca (AZN) Enhertu Receives EU Nod for Expanded Use
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AstraZeneca (AZN - Free Report) and its Japan-based partner Daiichi Sankyo’s cancer drug, Enhertu (trastuzumab deruxtecan), received European Union (EU) approval for use in adults with unresectable or metastatic HER2-positive breast cancer treated with a prior anti-HER2-based regimen.
The approval comes right after AstraZeneca received Committee for Medicinal Products for Human Use (CHMP) recommendation for this expanded use last month. In May 2022, the drug was approved for use in the United States for a similar indication.
The EU approval broadens Enhertu’s label across Europe to earlier use in metastatic breast cancer. Enhertu is already approved for the later-line treatment of patients with HER2-positive metastatic breast cancer in Europe
Following approval for this expanded use in EU, AstraZeneca is due to make a milestone payment of $75 million to partner Daiichi Sankyo,
The approval is based on results from the DESTINY-Breast03 phase III study, which demonstrated that treatment with Enhertu reduced the risk of disease progression or death by 72% compared with Roche’s (RHHBY - Free Report) Kadcyle (trastuzumab emtansine).
Roche’s Kadcyle is approved in the EU for treating adults with HER2-positive metastatic breast cancer previously treated with Roche’s drug, Herceptin (trastuzumab) and a taxane, in combination or separately. In 2019, Kadcyle also received FDA approval for use in patients with HER2-positive early breast cancer (EBC) after treatment with taxane and Herceptin
Shares of AstraZeneca have increased 19% year to date compared with the industry’s 5.3% increase.
Image Source: Zacks Investment Research
Enhertu is currently approved for previously-treated HER2-positive metastatic breast and HER2-positive metastatic gastric cancer in several countries. It is also being evaluated for other HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.
Last month, AstraZeneca reported positive results from a pivotal DESTINY-Breast04 phase III study evaluating Enhertu in previously treated patients with HER2-low unresectable and/or metastatic breast cancer with hormone receptor (HR) positive or HR-negative disease.
The study achieved both its primary and secondary endpoint of progression-free survival and overall survival in patients with HER2-low metastatic breast cancer with HR-positive disease, reducing the risk of disease progression by 49% and 36%, respectively, in comparison to chemotherapy.
Merck’s earnings per share estimates for 2022 have remained steady at $7.31 for the past 30 days. The same for 2023 has decreased from $7.19 to $7.15 in the same time frame. Shares of MRK have returned 22.6% in the year-to-date period.
Earnings of Merck missed estimates in one of the trailing four quarters and beat the same on the remaining three occasions, the average surprise being 13.42%.
BioNTech’s earnings per share estimates for 2022 have narrowed from $34.79 to $33.51 in the past 30 days. The same for 2023 has increased from $15.60 to $16.27 in the same time frame.
Earnings of BioNTech beat estimates in all of the trailing four quarters, the average surprise being 13.42%.
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AstraZeneca (AZN) Enhertu Receives EU Nod for Expanded Use
AstraZeneca (AZN - Free Report) and its Japan-based partner Daiichi Sankyo’s cancer drug, Enhertu (trastuzumab deruxtecan), received European Union (EU) approval for use in adults with unresectable or metastatic HER2-positive breast cancer treated with a prior anti-HER2-based regimen.
The approval comes right after AstraZeneca received Committee for Medicinal Products for Human Use (CHMP) recommendation for this expanded use last month. In May 2022, the drug was approved for use in the United States for a similar indication.
The EU approval broadens Enhertu’s label across Europe to earlier use in metastatic breast cancer. Enhertu is already approved for the later-line treatment of patients with HER2-positive metastatic breast cancer in Europe
Following approval for this expanded use in EU, AstraZeneca is due to make a milestone payment of $75 million to partner Daiichi Sankyo,
The approval is based on results from the DESTINY-Breast03 phase III study, which demonstrated that treatment with Enhertu reduced the risk of disease progression or death by 72% compared with Roche’s (RHHBY - Free Report) Kadcyle (trastuzumab emtansine).
Roche’s Kadcyle is approved in the EU for treating adults with HER2-positive metastatic breast cancer previously treated with Roche’s drug, Herceptin (trastuzumab) and a taxane, in combination or separately. In 2019, Kadcyle also received FDA approval for use in patients with HER2-positive early breast cancer (EBC) after treatment with taxane and Herceptin
Shares of AstraZeneca have increased 19% year to date compared with the industry’s 5.3% increase.
Image Source: Zacks Investment Research
Enhertu is currently approved for previously-treated HER2-positive metastatic breast and HER2-positive metastatic gastric cancer in several countries. It is also being evaluated for other HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.
Last month, AstraZeneca reported positive results from a pivotal DESTINY-Breast04 phase III study evaluating Enhertu in previously treated patients with HER2-low unresectable and/or metastatic breast cancer with hormone receptor (HR) positive or HR-negative disease.
The study achieved both its primary and secondary endpoint of progression-free survival and overall survival in patients with HER2-low metastatic breast cancer with HR-positive disease, reducing the risk of disease progression by 49% and 36%, respectively, in comparison to chemotherapy.
AstraZeneca PLC Price
AstraZeneca PLC price | AstraZeneca PLC Quote
Zacks Rank and Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall health sector include Merck & Co. (MRK - Free Report) , carrying a Zacks Rank #1 (Strong Buy) and BioNTech (BNTX - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Merck’s earnings per share estimates for 2022 have remained steady at $7.31 for the past 30 days. The same for 2023 has decreased from $7.19 to $7.15 in the same time frame. Shares of MRK have returned 22.6% in the year-to-date period.
Earnings of Merck missed estimates in one of the trailing four quarters and beat the same on the remaining three occasions, the average surprise being 13.42%.
BioNTech’s earnings per share estimates for 2022 have narrowed from $34.79 to $33.51 in the past 30 days. The same for 2023 has increased from $15.60 to $16.27 in the same time frame.
Earnings of BioNTech beat estimates in all of the trailing four quarters, the average surprise being 13.42%.