A new pharmaceutical manufactured by Novartis, ceritinib, is showing promising results in patients with a rare form of lung cancer. The drug targets a specific gene mutation that is present in about half of mesothelioma patients. Lung cancer lawyers at Pintas & Mullins report on this new drug and what it could mean for mesothelioma cancer care.
Ceritinib (previously known as LDK378) targets a gene known as ALK, which plays a crucial role in a small subset of lung cancers. It is somewhat similar to Pfizer's drug Xalkori, however recent reports indicate ceritinib is actually 20 times more effective in deactivating the mutated ALK gene. That report was recently published in the New England Journal of Medicine.
The study examined nearly 115 patients with ALK-mutated lung cancer, including 83 patients who had been previously prescribed to Xalkori and stopped responding to the treatment. At the end of the trial, 56% of patients responded favorably to the new treatment, with 62% of those who had been on Xalkori responded favorably. Notable side effects included dehydration, vomiting and diarrhea.
Unfortunately, patients prescribed to Xalkori typically develop a resistance to the drug, and the same seems to be true for ceritinib. The average amount of time before patients' lung cancer progressed again was about seven months.
Several other drug companies beyond are developing ALK-inhibitor drugs, including Ariad Pharmaceuticals and Chugai Pharmaceutical, which is based in Japan, and is partnering with Roche Holding. Pfizer is also in the midst of making a follow-up drug to Xalkori, which was approved in 2011. At the time, Xalkori was a milestone in lung cancer pharmaceutical development because no other drug specifically targeted the ALK gene.
Novartis has already filed for premarket approval for ceritinib to the FDA, which is reviewing the drug under its "breakthrough therapy designation." Drugs in this class are typically experimental, and may be expedited through the approval process due to striking promise in trials and high demand for terminally ill patients. A decision on the drug is expected later in 2014.
Medical researchers believe the next step will be to study and prescribe ceritinib in combination with other targeted treatments. Such drugs could include immunotherapy treatments, which are intended to activate the body's natural immune system to fight tumors.