The Food and Drug Administration has recently approved a new drug from AstraZeneca for patients with lung cancer that has continued to spread despite treatments.
According to the Centers for Disease Control and Prevention, lung cancer is the most deadly form of cancer in the United States. A majority of patients have a form of the disease known as non-small cell lung cancer. Of those patients, around 10% develop a mutation in a gene known as EGFR. Of those patients about 2/3 then develop the T790M mutation during treatment which is what Tagrisso targets.
Tagrisso is a daily pill that is intended for patients whose tumors have a genetic mutation that affects their growth.
Tagrisso is the first drug for a subset of lung cancer patients. Another drug for this group of patients developed by Clovis Oncology Inc is also under consideration by regulators.
Tagrisso was developed in only two and a half years, which is record time. The drug entered its first human trial in 2013 and has sped through development thanks to a series of priority designations by the FDA.
The FDA approved the drug based on two studies of about 400 people that showed roughly 60% of patients treated with the drug had a partial or complete reduction of their tumor size.
The drug was approved under the FDA’s accelerated program. The accelerated program grants streamlined market access based on promising early-stage results.
Normally, company must run larger so-called phase-three trials before a drug can be submitted to regulators AstraZeneca is running a continuing phase-three clinical trial on Tagrisso in order to gather more information on the drug’s safety and effectiveness.
In addition, the FDA approved an accompanying diagnostic in order to test for the mutation that Tagrisso targets.
AstraZeneca U.S. said the company would launch the drug as soon as next week. The drug will be made available at a co-pay of as little as $25 per month.