For the first time, almost after two decades, a new drug has gained FDA approval for treating metastatic small cell lung cancer (SCLC). The drug, nivolumab, has been approved for those patients who have not gone through a successful platinum-based chemotherapy or any other type. Nivolumab now is the first ever immuno-oncology drug for this disease.
The study that backs up FDA’s approval involves patients who have metastatic or advanced tumors and platinum-based chemotherapy has failed to stop the progression of their cancer. 109 such patients were given 3mg/kg nivolumab, in every two weeks, without any regard to PD-L1 status. Tumor assessment was started six weeks after the treatment and subsequent six weeks for six months. Later on, the assessment was done after every 12 weeks.
According to the data from Blinded Independent Central Review, 13 patients showed a complete response to the therapy, 12 patients exhibited partial response and 1 patient showed a full response to the therapy. Average response duration was 17.9 months for a patient who showed a response.
As for the AEs (adverse events), dyspnea, pneumonitis, pneumonia, dehydration and pleural effusion were noticed in 2% of the patients. Common AEs consisted of constipation, cough, dyspnea, musculoskeletal pain, low appetite, diarrhea, nausea and fatigue in about 20% of the patient.
Keeping the overall response rate in view, FDA gave accelerated approval to the use of Nivolumab. The response duration was also better. Approval will be continued if further supported by future studies.