AstraZeneca announced on Tuesday that the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for its cancer drug Imfinzi and granted priority review for a new dosing to treat patients with lung and bladder cancer.
AstraZeneca (AZN) said that the FDA’s priority review for Imfinzi is for a new four-week, fixed-dose regimen for the treatment in patients with non-small cell lung cancer (NSCLC) and bladder cancer. The new dosing would cut medical visits by half, the company said.
The British drugmaker added that if approved, Imfinzi could be administered intravenously every four weeks at a fixed dose of 1500mg in patients with unresectable stage III NSCLC who have undergone chemoradiation therapy and those with previously treated advanced bladder cancer.
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 tumour’s immune-evading tactics and releasing the inhibition of immune responses.
“The new less-frequent dosing option for non-small cell lung cancer and bladder cancer will simplify and improve treatment by enabling continuity of care while minimising the risk of exposure to infection in the healthcare setting,” Dave Fredrickson, AstraZeneca’s Executive VP of Oncology said. “This takes on particular urgency during the current pandemic, as doctors care for patients at high risk of COVID-19 complications. We are working with health authorities in the US and other countries to bring the option of four-week, fixed dosing for Imfinzi to patients around the world as soon as we can.”
The FDA grants priority review to applications for medicines that offer significant advances over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date, which is the FDA action date for their regulatory decision, is during the fourth quarter of 2020.
The new dosing, if approved would be available as an alternative to the approved weight-based dosing of 10mg/kg every two weeks. AstraZeneca added that the sBLA was based on data from several Imfinzi clinical trials, including results from the Phase III CASPIAN trial which used the four-week, fixed-dose regimen during maintenance.
Imfinzi is approved for the treatment of unresectable, stage III NSCLC after chemoradiation therapy in the US, Japan, China, across the EU and in many other countries. It is also approved for previously treated patients with advanced bladder cancer in the US and several other countries.
AstraZeneca shares have advanced 13% this year as the drugmaker joined the list of companies engaged in the development of a potential coronavirus vaccine. Looking ahead, the $81.84 average analyst price target puts the upside potential at a promising 45% in the coming 12 months.
Overall, the stock scores a Strong Buy consensus from the analyst community based on 3 unanimous Buy ratings. (See AstraZeneca stock analysis on TipRanks)
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