PharmaMar lung cancer drug lurbinectedin gets FDA orphan drug designation

Spanish pharma company PharmaMar’s lurbinectedin has secured orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of small cell lung cancer.

Lurbinectedin has been designed to inhibit the RNA polymerase II enzyme which is important for the transcription process that is over-activated in tumors with transcription addiction, according to PharmaMar.

Luis Mora – Managing Director of the Oncology Business Unit of PharmaMar, said: “We are delighted to receive this orphan drug designation as it underscores the great need for innovative, effective treatments for this cancer, and recognizes the potential benefits that lurbinectedin may provide for patients with small cell lung cancer.

“Receiving orphan drug designation for the treatment of small cell lung cancer (SCLC) is a significant regulatory milestone in the development of lurbinectedin.”

An aggressive cancer, small cell lung cancer usually presents with distant metastases and has spread already at the time of diagnosis. As a result, it limits the role of traditional methods and poses a worse prognosis in comparison to other lung cancer forms, said PharmaMar.

The FDA’s orphan drug designation is given to medications that are being developed for the treatment of rare diseases or disorders that affect less than 200,000 people in the US.

At the end of last month, PharmaMar said that a pivotal phase 3 trial named as ATLANTIS for evaluating lurbinectedin in combination with doxorubicin in relapsed small-cell lung cancer has achieved its goal of patient recruitment by enrolling 600 patients. The lurbinectedin-doxorubicin combination will be evaluated against physician’s choice of Topotecan or CAV (cyclophosphamide, adriamycin, vincristine).

For more pharma regulatory news and updates on PharmaMar and lurbinectedin, keep following PharmaNewsDaily.com.