AstraZeneca Plc. (AZN - Free Report) announced that the FDA has granted a priority review to a supplemental biologics license application (sBLA) seeking approval for a less-frequent, fixed-dose regimen of Imfinzi for its approved indications. Imfinzi is presently approved to treat stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy and previously treated advanced bladder cancer.
The FDA has set an action date inthe fourth quarter of 2020.
The FDA generally grants a priority review to drugs with the potential to treat a serious condition and if approved, would substantially improve safety or effectiveness.
If approved Imfinzi could be administered intravenously every four weeks at a fixed dose of 1500 mg. The new dosing would be available as an alternative to the approved weight-based dosing of 10mg/kg every two weeks. The new less-frequent dosing option, if approved, will be a simplified option and also reduce risk of exposure to infection as the number of visits by patients will be reduced by half. Hence, their chances of getting infected will also be reduced.
This year so far, AstraZeneca’s shares have risen 13% compared with the industry’s growth of 1.9%.
Other than the approved indications in NSCLC and bladder cancer, the FDA also granted approval to Imfinzi in March for the first-line treatment of extensive-stage small cell lung cancer —the most aggressive type of lung cancer.
Imfinzi contributed $954 million of revenues in the first half of 2020, representing growth of about 51% year over year and contributing about 8% of total product sales of the company.
Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses.
However, other companies having PD-L1 inhibitors, which makes the market for Imfinzi competitive, areMerck’s (MRK - Free Report) Keytruda, Bristol-Myers’ (BMY - Free Report) Opdivo and Roche’s (RHHBY - Free Report) Tecentriq. Several other pharma companies are also developing immunotherapies in different stages in clinical studies.
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AstraZeneca Plc. (AZN - Free Report) announced that the FDA has granted a priority review to a supplemental biologics license application (sBLA) seeking approval for a less-frequent, fixed-dose regimen of Imfinzi for its approved indications. Imfinzi is presently approved to treat stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy and previously treated advanced bladder cancer.
The FDA has set an action date inthe fourth quarter of 2020.
The FDA generally grants a priority review to drugs with the potential to treat a serious condition and if approved, would substantially improve safety or effectiveness.
If approved Imfinzi could be administered intravenously every four weeks at a fixed dose of 1500 mg. The new dosing would be available as an alternative to the approved weight-based dosing of 10mg/kg every two weeks. The new less-frequent dosing option, if approved, will be a simplified option and also reduce risk of exposure to infection as the number of visits by patients will be reduced by half. Hence, their chances of getting infected will also be reduced.
This year so far, AstraZeneca’s shares have risen 13% compared with the industry’s growth of 1.9%.
Other than the approved indications in NSCLC and bladder cancer, the FDA also granted approval to Imfinzi in March for the first-line treatment of extensive-stage small cell lung cancer —the most aggressive type of lung cancer.
Imfinzi contributed $954 million of revenues in the first half of 2020, representing growth of about 51% year over year and contributing about 8% of total product sales of the company.
Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses.
However, other companies having PD-L1 inhibitors, which makes the market for Imfinzi competitive, areMerck’s (MRK - Free Report) Keytruda, Bristol-Myers’ (BMY - Free Report) Opdivo and Roche’s (RHHBY - Free Report) Tecentriq. Several other pharma companies are also developing immunotherapies in different stages in clinical studies.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases. Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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