FDA NewsDrug Pipeline

FDA grants orphan drug designation to VS-5584 for mesothelioma

The FDA granted orphan drug designation to VS-5584 for the treatment of mesothelioma, according to a press release from the drug’s manufacturer.

VS-5584 (Verastem) has demonstrated potent and highly selective activity against class 1 PI3K enzymes and dual inhibitory actions against mTORC1 and mTORC2, according to a press release issued by Verastem.

“This is an important regulatory milestone for Verastem and, together with our European orphan medicinal product designation, will facilitate our global development of VS-5584 to help improve the available treatment options for patients suffering from this highly aggressive cancer,” Robert Forrester, president and CEO of Verastem, said in a press release. “We look forward to taking full advantage of the opportunities that orphan designation allows in order to bring this potential new treatment option to patients as rapidly as possible.”

Verastem is currently conducting a phase 1 study to evaluate the combination of VS-5584 and VS-6063 (defactinib) in patients with relapsed or progressive malignant pleural mesothelioma. Preclinical data demonstrated synergistic activity of VS-5584 and defactinib in mesothelioma models in vitro and in vivo.

A phase 1 dose escalation study also is underway to evaluate VS-5584 in patients with advanced solid tumors.

The FDA granted orphan drug designation to VS-5584 for the treatment of mesothelioma, according to a press release from the drug’s manufacturer.

VS-5584 (Verastem) has demonstrated potent and highly selective activity against class 1 PI3K enzymes and dual inhibitory actions against mTORC1 and mTORC2, according to a press release issued by Verastem.

“This is an important regulatory milestone for Verastem and, together with our European orphan medicinal product designation, will facilitate our global development of VS-5584 to help improve the available treatment options for patients suffering from this highly aggressive cancer,” Robert Forrester, president and CEO of Verastem, said in a press release. “We look forward to taking full advantage of the opportunities that orphan designation allows in order to bring this potential new treatment option to patients as rapidly as possible.”

Verastem is currently conducting a phase 1 study to evaluate the combination of VS-5584 and VS-6063 (defactinib) in patients with relapsed or progressive malignant pleural mesothelioma. Preclinical data demonstrated synergistic activity of VS-5584 and defactinib in mesothelioma models in vitro and in vivo.

A phase 1 dose escalation study also is underway to evaluate VS-5584 in patients with advanced solid tumors.