According to a story from Medpage Today, the US Food and Drug Administration has approved the drug lurbinectedin (marketed as Zepzelca), developed by Jazz Pharmaceuticals, as a treatment for metastatic small cell lung cancer (cancer that has spread beyond the tissue of origin). The medication was approved under Accelerated Approval protocols. The drug is cleared for use as a second-line treatment in patients who have seen progression of their disease during or after treatment with platinum chemotherapy.
About Small Cell Lung Cancer
Small cell lung cancer is an aggressive type of lung cancer that is responsible for only about 10 to 15 percent of lung cancer cases. Lung cancer as a whole is not considered rare, but small cell lung cancer is. While smoking tobacco is a risk factor for lung cancers of all types, the connection between smoking and small cell carcinoma is particularly strong. In fact, it appears almost exclusively in people who have smoked. That being said, it is still possible for people who were never regular smokers to get it. Symptoms of this cancer include chest pain, coughing up blood, weight loss, and shortness of breath. This cancer metastasizes rapidly and most patients are diagnosed when this process has already begun. This cancer relapses easily and the five year survival rate is meager at just 20 percent and is even lower for metastatic disease. To learn more about small cell lung cancer, click here.
An Urgent Need
With poor survival rates and an overwhelmingly strong chance of relapse, it is clear that there is a dire need for more effective therapies in small cell lung cancer. In a phase 2 clinical trial including a total of 105 patients, the drug produced an overall response rate of 30 percent, with a median response duration of 5.1 months. These stats may not seem all that impactful, but in a disease as deadly as small cell lung cancer, even this performance is a sign of progress.
About Accelerated Approval
Zepzelca was approved under Accelerated Approval, an FDA program that allows for certain drugs to be approved more quickly based on findings using a ‘surrogate endpoint.’ This endpoint is not necessarily a measure of direct benefit, but must only predict clinical benefit. Such a drug must treat a severe, life-threatening condition and fulfill an unmet medical need. A drug that is approved under this program will still need to undergo continued tests in phase 4 trials to prove its effect; if the trial results are positive, the drug will ultimately be approved in the traditional process; if not, the drug will be pulled from shelves, never to return.
