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AstraZeneca PLC (AZN - Free Report) announced that the FDA has accepted for review its supplemental new drug application (sNDA), seeking expanded use for its blockbuster drug Tagrisso (osimertinib) as a combination treatment in advanced lung cancer.
The company is looking to get approval for Tagrisso in combination with chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations.
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected in the first quarter of 2024.
The FDA generally grants a priority review to drugs with the potential to treat a serious condition. These, if approved, would substantially improve safety or effectiveness.
Currently, Tagrisso is already approved as a monotherapy for treating EFGR-mutated NSCLC.
The latest sNDA was based on data from the phase III FLAURA-2 study.
Data from the study showed that treatment with the Tagrisso+chemotherapy combination reduced the risk of disease progression or death by 38%. The study data also suggested that the Tagrisso+chemotherapy combination extended median progression-free survival by nearly nine and a half months.
Shares of AstraZeneca failed to deliver any returns to investors in the year-to-date period compared with the industry’s increase of 8.5%.
Image Source: Zacks Investment Research
Tagrisso has been one of the key revenue drivers for AstraZeneca. In the first six months of 2023, Tagrisso generated sales worth $2.9 billion, reflecting an increase of 12% year over year at constant exchange rates (“CER”). If approved for the new indication, sales of the drug are likely to rise further as it will be able to address a broader patient population.
AstraZeneca remains focused on strengthening its oncology product portfolio through label expansions of existing products. The company’s oncology franchise clocked sales worth $8.3 billion during the first half of 2023, increasing 21% year over year at CER.
AstraZeneca’s oncology business is now annualizing at almost $15 billion. Constant label expansion for key cancer drugs is likely to boost sales further in the days ahead.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for Neurocrine Biosciences’ 2023 earnings per share have risen from $2.17 to $2.19. During the same period, estimates for 2024 have risen from $4.77 to $4.86 per share. Year to date, shares of NBIX have lost 4.9%.
Earnings of Neurocrine Biosciences beat estimates in one of the last four quarters and missed the same on the other three occasions. NBIX delivered a four-quarter negative average earnings surprise of 105.45%.
In the past 60 days, estimates for Sarepta’s 2023 loss per share have improved from $9.73 to $9.19. During the same period, loss per share estimates for 2024 have narrowed from $1.66 to $1.00. Year to date, shares of SRPT have declined 9.3%.
Earnings of Sarepta Therapeutics beat estimates in three of the trailing four quarters and missed the mark on the other occasion. On average, SRPT delivered a negative earnings surprise of 5.15% in the last four quarters.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have improved from $6.54 to $4.89. During the same period, loss per share estimates for 2024 have narrowed from $5.14 to $4.02. Year to date, shares of MEIP have rallied 40.4%.
Earnings of MEI Pharma beat estimates in three of the trailing four quarters and met the same on the other occasion. On average, MEIP came up with an average four-quarter earnings surprise of 53.58%.
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AstraZeneca's (AZN) Tagrisso Combo Gets FDA's Priority Review
AstraZeneca PLC (AZN - Free Report) announced that the FDA has accepted for review its supplemental new drug application (sNDA), seeking expanded use for its blockbuster drug Tagrisso (osimertinib) as a combination treatment in advanced lung cancer.
The company is looking to get approval for Tagrisso in combination with chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations.
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected in the first quarter of 2024.
The FDA generally grants a priority review to drugs with the potential to treat a serious condition. These, if approved, would substantially improve safety or effectiveness.
Currently, Tagrisso is already approved as a monotherapy for treating EFGR-mutated NSCLC.
The latest sNDA was based on data from the phase III FLAURA-2 study.
Data from the study showed that treatment with the Tagrisso+chemotherapy combination reduced the risk of disease progression or death by 38%. The study data also suggested that the Tagrisso+chemotherapy combination extended median progression-free survival by nearly nine and a half months.
Shares of AstraZeneca failed to deliver any returns to investors in the year-to-date period compared with the industry’s increase of 8.5%.
Image Source: Zacks Investment Research
Tagrisso has been one of the key revenue drivers for AstraZeneca. In the first six months of 2023, Tagrisso generated sales worth $2.9 billion, reflecting an increase of 12% year over year at constant exchange rates (“CER”). If approved for the new indication, sales of the drug are likely to rise further as it will be able to address a broader patient population.
AstraZeneca remains focused on strengthening its oncology product portfolio through label expansions of existing products. The company’s oncology franchise clocked sales worth $8.3 billion during the first half of 2023, increasing 21% year over year at CER.
AstraZeneca’s oncology business is now annualizing at almost $15 billion. Constant label expansion for key cancer drugs is likely to boost sales further in the days ahead.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Neurocrine Biosciences, Inc. (NBIX - Free Report) , Sarepta Therapeutics, Inc. (SRPT - Free Report) and MEI Pharma, Inc. (MEIP - Free Report) , sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Neurocrine Biosciences’ 2023 earnings per share have risen from $2.17 to $2.19. During the same period, estimates for 2024 have risen from $4.77 to $4.86 per share. Year to date, shares of NBIX have lost 4.9%.
Earnings of Neurocrine Biosciences beat estimates in one of the last four quarters and missed the same on the other three occasions. NBIX delivered a four-quarter negative average earnings surprise of 105.45%.
In the past 60 days, estimates for Sarepta’s 2023 loss per share have improved from $9.73 to $9.19. During the same period, loss per share estimates for 2024 have narrowed from $1.66 to $1.00. Year to date, shares of SRPT have declined 9.3%.
Earnings of Sarepta Therapeutics beat estimates in three of the trailing four quarters and missed the mark on the other occasion. On average, SRPT delivered a negative earnings surprise of 5.15% in the last four quarters.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have improved from $6.54 to $4.89. During the same period, loss per share estimates for 2024 have narrowed from $5.14 to $4.02. Year to date, shares of MEIP have rallied 40.4%.
Earnings of MEI Pharma beat estimates in three of the trailing four quarters and met the same on the other occasion. On average, MEIP came up with an average four-quarter earnings surprise of 53.58%.