The government said Tuesday Il-yang Pharmaceutical’s Supect (ingredient: radotinib) would lose its second-line indication for treatment of chronic myelogenous leukemia.
The medicine had obtained approval as a second-line treatment for patients with chronic myelogenous leukemia who do not respond to conventional therapies, on the condition that the drugmaker conducts a clinical study to confirm the efficacy after the submitted results of the phase 2 trials.
Supect can also be used as first-line therapy for patients who are newly diagnosed with chronic myelogenous leukemia.
While Supect failed to present the confirming clinical data for second-line treatment, other rivals have submitted their clinical results to the regulator and won the nod for a second-line remedy. Thus, the latest government decision will be a hurdle for Supect to increase sales, observers said.
According to the minutes of the Ministry of Food and Drug Safety’s central pharmaceutical affairs advisory committee, Il-yang Pharm was supposed to submit the results of phase 3 clinical trials with confirming therapeutic effects of Supect by Jan. 4. However, the company managed to file a study plan on Nov. 10, 2017, which was near the deadline of the study results submission, citing the difficulty of recruiting patients.
Even though it was difficult to recruit patients, the ministry said the company did not do its best and submitted the plan at a time when the deadline was imminent. The ministry sought advice from the central pharmaceutical affairs advisory committee whether the regulator should maintain Supect’s second indication.
“The drugmaker had approval conditions at the time of receiving the nod but submitted the clinical trials plan in 2017. I find it appropriate to delete the indication and strictly apply the rules,” a committee member said in the minutes.
Another committee member also said, “It is not desirable to extend approval conditions. This is not a cancellation of approval but a deletion of an indication. Thus, if the company submits results of phase 3 clinical trials, it can add the indication for a second-line treatment again.”
The committee also pointed out that Il-yang Pharma did not make enough effort to keep Supect’s indication for second-line therapy.
“Considering that the application for the clinical trial plan has been delayed for a considerable period and that alternative drugs already exist, I find no problem to delete the indication for second-line treatment,” a third member said.
The deletion of the indication will cause no harm to patients because those who have used Supect for a second-line treatment will continue to receive the insurance benefits.
According to data submitted by Il-yang Pharm, Sprycel has 3 percent share in the second-line treatment market, Tasigna, 3 percent, and Supect, 2 percent.
Citing such alternatives, six out of the seven members of the committee said the government did not need to keep Supect’s indication.
Il-yang Pharm gained the sales license for Supect as the nation’s 18th novel drug in 2012.
The government grants the green light to particular drugs urgently needed for seriously ill patients such as anti-cancer therapies, even when they have results of phase 2 trials only. Such nod is given on the condition that the drug should prove safety and efficacy through a phase-3 study.
Sprycel and Tasigna also earned conditional approval. However, makers of the two drugs had submitted phase-3 trials results in 2010. The two drugs are now used as second-line treatments.