FDA Speeds Up Review of Novel Small Cell Lung Cancer Drug

A novel small cell lung cancer drug has received a fast track designation by the FDA.

The Food and Drug Administration (FDA) granted a Fast Track Designation to the novel drug, SNB-101, for the treatment of certain patients with small cell lung cancer (SCLC), according to a press release from SN Bioscience Co., the manufacturer of the drug.

The intention of Fast Track Designations, according to the FDA, is to speed up the development and review of drugs that can fill an unmet need in the treatment of serious conditions. The press release noted that with the designation, SNB-101 may be able to be commercialized immediately after the completion of phase 2 trials.

SCLC makes up only approximately 10% to 15% of all lung cancer diagnoses. The disease tends to progress quicker than non-small cell lung cancer and most people experience recurrence after treatment, according to the American Cancer Society.

Preliminary data from a phase 1 trial of SNB-101 in patients with advanced solid cancers were presented at the 2023 European Society of Medical Oncology Congress.

When the researchers last collected data in 2023, 14.29% of the patients who received SNB-101 responded to the therapy. All responses were partial responses, meaning that the cancer shrunk but did not disappear. The disease control rate, which is when patients’ cancer shrinks or does not grow, was 42.86%.

Further, the median progression-free survival (time patients live without their cancer worsening) was 1.97 months, and the median overall survival (time patients live before death of any cause) was 6.83 months. Patients with SCLC were among the group of individuals who responded.

The most common treatment-related side effects were neutropenia, which is a decrease in a type of white blood cells called neutrophils (occurred in 61.9% of patients) and overall white blood cell count decrease (28.6%). Other common side effects were nausea (23.8%), a decrease in healthy red blood cells (19%) and a decrease in platelets (19%).

Additionally, the most common moderate to severe (grade 3/4) side effects were neutropenia (33.3%), white blood cell count decrease (14.3%) and platelet decrease (9.5%).

According to the SN Bioscience Co. press release, both preclinical (not conducted in humans) and phase 1 data also showed that the SNB-101 reduced digestive system-related side effects, such as nausea, vomiting and diarrhea, compared to other cancer drugs currently available.

Patients with multiple different cancer types were involved in the phase 1 trial. Seven had colorectal cancer, five had gastric cancer, three had SCLC, two had NSCLC, two had head and neck cancer, one had esophageal cancer and one had soft-tissue sarcoma.

READ MORE: Small Cell Lung Cancer: It’s a Time to Be Hopeful

In addition to the Fast Track Designation for SCLC, SNB-101 also received orphan drug designations for SCLC and pancreatic cancer. Orphan drug designations give incentives to pharmaceutical companies and drug developers to create therapies for rare and serious illnesses.

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