Ym Biosciences’ Nimotuzumab Approved For Marketing In Mexico

YM BioSciences has reported that nimotuzumab has been approved for marketing in Mexico. YM BioSciences also announced that it has enrolled the first two patients in its randomised, double-blind trial evaluating nimotuzumab in patients with brain metastases from non-small-cell lung cancer (NSCLC).

The company has enrolled and treated the first two patients in its multinational randomised, double-blind trial evaluating nimotuzumab plus whole-brain radiation therapy (WBRT) to WBRT alone in patients with brain metastases from NSCLC.

Reportedly, the trial is designed enroll approximately 88 patients over twelve months followed by a twelve-month follow-up period and will likely include12 investigational centers in Canada and additional centers in other countries.

The company said that Nimotuzumab (200mg IV infusions) will be administered weekly during radiotherapy and following radiotherapy until disease progression, unacceptable toxicity or at the discretion of the physician.

Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day. Patients will be assessed by laboratory tests, imaging studies, standardised neurologic examination, and neurologic symptoms. The primary efficacy endpoint is intracranial disease progression over six months.

However, the secondary endpoints are overall survival (OS); time to neurologic progression (TNP) or death with evidence of neurologic progression; OS rate at six months; time to intracranial disease progression; and time to overall progression.

David Allan, chairman and CEO of YM BioSciences, said: “Mexico is the 21st country to have approved nimotuzumab for marketing and, while YM’s license for major market territories for nimotuzumab does not include Mexico, this approval reflects the growing recognition throughout much of the world of the value to patients of our drug and the progress being made in its commercialisation.

“As part of YM’s registration strategy for nimotuzumab, we were also pleased to report the opening of this second of two randomised, double-blind trials that YM is conducting in Canada and which are both now being expanded internationally.”