On September 28, 2020 xCures, a clinical study platform provider, reported the US Food and Drug Administration (FDA) granted their IND for an intermediate Expanded Access Program (EAP) for the ERK inhibitor ulixertinib (BVD-523) (Press release, xCures, SEP 28, 2020, View Source [SID1234567705]).
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Ulixertinib is being developed by BioMed Valley Discoveries (BVD), a clinical stage biotechnology company, as a treatment for patients with MAPK pathway aberrant cancer, including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK, mutations.
The EAP is open across the United States to adolescent and adult cancer patients who cannot access an open clinical trial for the investigation of ulixertinib (BVD-523).
"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," says Mika Newton, CEO of xCures, Inc. "xCures’ programs uniquely capture high-value evidence related to the safety and efficacy from this expanded set of patients."
This intermediate-sized expanded access program (NCT04566393) is currently open and available for physicians interested in treating their patients. Physicians can reach out to [email protected] for more information. Patients can register and find more information at enroll.xcures.com/uli-eap or receive additional information via xCures patient advocacy partner Cancer Commons (www.cancercommons.org).
About ulixertinib (BVD-523):
Ulixertinib is a first-in-class and best-in-class small-molecule inhibitor of extracellular signal-regulated kinase (ERK) family kinases (ERK1 and ERK2) that is being developed as a novel anti-cancer drug. ERK kinases are downstream components of the mitogen-activated protein kinase (MAPK) signaling cascade (RAS-RAF-MEK-ERK). Ulixertinib has demonstrated promising early efficacy for patients with tumors harboring alterations in the MAPK pathway, including atypical (non-V600) BRAF alterations, for which there are currently no approved targeted agents.
About Expanded Access:
Expanded access, which is often called "compassionate use," is the use of an unapproved drug for treatment of patients with serious or life-threatening illnesses outside of a clinical trial. Expanded access is subject to oversight from the US FDA in accordance with the regulations outlined in 21 CFR 312.305.
About the Program:
This Expanded Access program provides ulixertinib for compassionate use in advanced cancer patients with a MAPK pathway-altered solid tumor(s) who have exhausted available therapies. The protocol aims to collect sufficient information about the patient’s treatment to provide a complete and accurate case report to health authorities using real-world data collection to assess response to treatment, safety, tolerability, and quality-of-life.