A drug meant for a hard-to-treat lung cancer has just been granted accelerated approval with conditions by the US Food and Drug Administration (FDA).
According to the official press release by the agency on Friday, Dec. 11, a drug called Alecensa (alectinib) was granted accelerated approval after the initial clinical trials carried out by its manufacturer, Genentech, showed its efficacy for a group of lung cancer patients left with very little treatment choices.
These are people diagnosed with advanced non-small-cell lung cancer (NSCLC) with a gene mutation on anaplastic lymphoma kinase (ALK), which is present in at least 5% of NSCLC patients. Most of these lung cancer patients are provided with Xalkori (crizotinib), which is produced by Phizer. However, the drug doesn't have any effect on them, leaving them with almost no other viable option.
Further, these patients may already have a metastasis, which means the cancer cells have already spread to other parts of the body. For this specific group, it usually occurs in the brain.
The two studies conducted showed that Alecensa doesn't only reduce the size of the tumors but also promotes even complete decrease of metastasis to the brain. In the first trial, more than 3% of the participants experienced partial tumor shrinkage for 7.5 months. The length of time was longer among the second set of participants where 44% of them had tumor reduction for almost a year. Shrinkage of the secondary brain tumor was also detected among 61% of the patients with efficacy lasting for at least 9 months.
The medication, which Genentech is expected to release within the next two weeks in the US market, will be taken orally. Its active components then work against a protein that regulates ALK, preventing the cells from proliferating and spreading.
As part of the conditional approval, however, the company needs to carry out more tests. Currently, adverse side effects of the drug include slow heartbeat, lung inflammation, and sunburn during sunlight exposure.