CytoDyn Inc has announced that Health Canada has authorized the emergency use of leronlimab for the treatment of a patient with metastatic triple-negative breast cancer (mTNBC).
The company also said it will be filing for expanded access use for mTNBC patients in the US shortly.
“We now plan to ask Health Canada to allow expanded access use for all mTNBC patients who might have no other treatment options,” CytoDyn CEO Nader Pourhassan said in a statement.
READ: CytoDyn submits Breakthrough Therapy designation application to FDA for leronlimab as a treatment for Metastatic Triple-Negative Breast Cancer
“We are also seeking similar approvals in other countries and look forward to providing leronlimab for mTNBC patients, as well as for treatment of other solid tumor cancers, in the future,” Pourhassan added.
The US Food and Drug Administration (FDA) has granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat Human Immunodeficiency Virus (HIV) and metastatic cancer. The first indication is a combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC).
Contact Sean at sean@proactiveinvestors.com