Boehringer Ingelheim recently announced that its product Giotrif/Gilotrif (generically known as afatinib) has been accepted for final review by the US Food and Drug Administration and the European Medicines Agency for the treatment of patients with squamous cell carcinoma of the lung after failing on routine chemotherapy measures.
This review comes on the heels of the LUX-Lung 8 Phase III clinical trial on afatinib compared to erlotinib, another chemotherapy agent used to treat squamous cell carcinoma of the lung. The study revealed that afatinib prolonged survival rate and improved quality of life in patients who took the once-daily drug when compared to those who instead took erlotinib.
Because the drug was found to be superior to erlotinib and may be offered to all patients who fail first-line therapy for squamous cell cancer, the US FDA gave the drug the status of being an “orphan drug,” which means it is helpful but only necessary in rare medical conditions.
The LUX-Lung 8 clinical trial was the last of several similar trials showing the advantages of taking afatinib in patients suffering from non-small cell carcinoma of the lung, including squamous cell cancer. Squamous cell cancer of the lung is considered a very severe form of lung cancer, with an average survival rate of just about a year. With afatinib, this survival rate can extend beyond a year with patients experiencing a better quality of life during their remaining months.
As for side effects, the study was a mixed bag of some side effects being better in afatinib-taking patients while other side effects being better in erlotinib. For example, the incidence of diarrhea and mouth sores were higher in the afatinib group (10 percent grade 3 diarrhea in those taking afatinib versus 2 percent in the erlotinib group and a 4 percent incidence of mouth sores in afatinib group compared to 0 percent in the erlotinib group). On the other hand, the incidence of skin rashes or acne was worse in the erlotinib group at 10 percent versus 6 percent in the afatinib group.
By accepting the applications for afatinib through the US FDA and EMA, the way is paved for the use of this drug in patients who fail on the most established chemotherapy drugs for squamous cell carcinoma. The drug has not been studied yet as a first line treatment for cancer of the lung.