The Food and Drug Administration (FDA) has approved a novel drug that will be the first line of treatment for a less-common type of metastatic lung cancer.
The FDA has finally given its nod of approval to Iressa (getfinitib) developed by AstraZeneca to treat and delay the progression of the disease for patients with metastatic non-small cell lung cancer (NSCLC) with EGFR (epidermal growth factor receptor) mutations.
In its press release, the FDA has stressed the importance of the drug's approval, stating that lung cancer is the leading cancer-related death in the United States regardless of gender. Every year, more than 200,000 of people will be diagnosed with the disease while almost 160,000 are going to die.
Meanwhile, according to American Cancer Society, NSCLC accounts for at least 85% of the lung cancer cases, of which 10% can have the EGFR mutated genes.
The newly approved drug will act as an inhibitor and prevent the production of proteins that encourage the growth of cells that carry the mutated genes.
However, since the drug has a targeted approach, it's equally essential for doctors to identify correctly if NSCLC carries the gene mutation. Thus, along with the approval of Iressa is the confirmation of a diagnostic kit, which will act as a companion. The data obtained from the kit can help doctors determine whether Iressa is the best drug for the patient.
The drug's safety and efficacy have been demonstrated in two different trials. In one of the trials, around 100 NSCLC patients with EFGR mutation received the drug as first-line treatment. Half of the patients experienced tumor shrinkage, and the progression remained steady for at least half a year.
In the other trial, almost 200 patients received either Iressa or a combo of drugs called paclitaxel and carboplatin. The results suggest a longer survival rate for those on Iressa.
Once it is available in the market, the drug is given only once per day at 250 grams.
