Il-yang Pharm’s new leukemia treatment Supect (ingredient: radotinib) will have its post-marketing surveillance (PMS) extended due to a shortage in patient demand, the government said Tuesday.

The Ministry of Food and Drug Safety’s central pharmaceutical affairs council unveiled the results of a review on changing the period of the PMS and the number of cases.

A novel drug, like Supect, is eligible for the regulator’s re-evaluation after the drugmaker submits PMS data on the safety and efficacy of the drug in more than 6,000 cases for six years since the product launch. If the company presents objective and reasonable evidence, it can adjust the number of cases depending on the drug item.

Il-yang Pharm had asked the ministry to change the PMS condition to “two years of additional survey and the number of cases at 200,” saying the number of patients who used Supect during a clinical trial was too small.

According to the company, there are only 400 new patients with chronic myelogenous leukemia requiring a primary treatment, and 53 new patients with secondary treatment, each year. Due to the small number of patients, the company needs to change the number of PMS cases, it said. The drugmaker has reportedly secured 105 PMS cases for the six years.

After the review, the ministry has finally decided that Supect needs three years of additional PMS and increase of 300 or more cases.

Supect is the fourth new leukemia treatment developed after Gleevec and Tasigna by Novartis, and Sprycel by BMS. The drug is the first locally developed leukemia treatment.