People who suffer from lung cancer now have a second option to choose from. The FDA just gave accelerated approval for 90mg- and 30mg-Alunbrig. This oral treatment comes as a second option for those patients who are intolerant to crizotinib. Even if their condition improved, people whose cases have progressed will also be prescribed brigatinib (Alunbrig).
The FDA gave accelerated approval because clinical trials had shown the oral treatment had a good tumor response rate. Also, the duration of response is promising. To test the oral treatment, researchers monitored 222 ALK+ NSCLC patients whose cases were progressing even if they took crizotinib.
These people received a daily dose of 180mg or 90mg of brigatinib. From 222 participants, 219 were evaluated as safe. This shows that the oral treatment is safe enough for people with lung cancer. The company that produced the medicine had their researchers perform the clinical trials.
“The rapid development of Alunbrig is a tribute to the dedication of many research scientists and clinicians who carefully designed and developed this new medicine to address unmet medical needs in the ALK+ NSCLC patient population”, mentioned Takeda Pharmaceuticals medical chief, Andy Plump.
Alunbrig was developed by Ariad Pharmaceuticals. This company was purchased by Takeda this year in February, but the potential of the drug had been tested previously. Their observations indicated that it could inhibit tumor cells. Moreover, it can also inhibit the mutation that is resistant to crizotinib.
During the clinical trials, the patients first received a dosage of 90mg. If they could tolerate it, the researchers increased the dose to 180mg. Those who received only the 90mg dosage had an overall response rate of 48 percent, while the overall response rate for the 180mg dosage was 54 percent.
Like any other drug, this oral treatment for lung cancer had side effects. More than 25% of the participants had reactions including nausea, fatigue, and headaches. Severe adverse reactions were observed, too. More than 38% of the participants experienced pneumonia.
Unfortunately, two participants died after the clinical trials. Thus, researchers are warning patients not to use this oral treatment with strong CYP3A inducers and inhibitors, as it might have terrible side effects and even become lethal.
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