FDA Grants Expanded Access Program to Ulixertinib for MAPK Pathway Aberrant Cancer

The FDA granted the investigational new drug application for the ERK inhibitor ulixertinib (BVD-523) an immediate Expanded Access Program (EAP), according to an xCures press release.

The clinical stage biotechnology company, BioMed Valley Discoveries, is developing ulixertinib to treat patients with MAPK pathway aberrant cancer, including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations.

"xCures prospective real-world evidence generation capability transforms managed access programs such as the ulixertinib expanded access program by making them an efficient way for physicians and patients to gain access to promising therapies when clinical trials are not an option," Mika Newton, CEO of xCures, Inc., said in a press release.

The Expanded Access Program provides ulixertinib for compassionate use in patients with advanced cancer and a MAPK pathway-altered solid tumor(s). These patients have also exhausted all previously available lines of therapy.

The program collects data about a patient’s treatment to provide a complete and accurate case report to health authorities. These authorities use the data to “assess response to treatment, safety, tolerability, and quality-of-life.”

The Expanded Access Program involves the use of an unapproved drug for the treatment of patients with serious or life-threatening illnesses outside of a clinical trial setting.

"xCures' programs uniquely capture high-value evidence related to the safety and efficacy from this expanded set of patients," said Newton in a press release.

The best-in-class small-molecule inhibitor of extracellular signal-regulated kinase (ERK) family kinases (ERK1 and ERK2), ulixertinib, has demonstrated promising early efficacy for patients with “tumors harboring alterations in the MAPK pathway.”

According to xCures, this EAP is open across the United States to adolescent and adult patients with cancer who cannot access an open clinical trial to investigate ulixertinib.

Reference:

xCures announces the launch of a Compassionate Use program for ulixertinib (BVD-523) [news release]. San Francisco, California. Published September 28, 2020. https://www.prnewswire.com/news-releases/xcures-announces-the-launch-of-a-compassionate-use-program-for-ulixertinib-bvd-523-301139076.html. Accessed September 29, 2020.