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30 Sep 2020

USFDA granted expanded access to investigational ERK inhibitor ulixertinib

The US Food and Drug Administration has granted expanded access to BioMed Valley Discoveries’ investigational ERK inhibitor ulixertinib for patients with cancers driven by alterations in the MAPK pathway.

The drug will be made available through an intermediate-sized expanded access program (EAP) facilitated by xCures, a company that uses machine learning algorithms to identify cancer patients for drug trials and collects real-world data on patients’ outcomes within those studies, which in turn can be used to support regulatory submissions for investigational drugs.

What is Expanded Access Use (also called compassionate use)?

The EAP for ulixertinib will be open to adolescent and adult cancer patients who have exhausted other treatment options and cannot access ulixertinib through another open clinical trial. Patients must harbor MAPK pathway alterations in genes such as KRAS, NRAS, HRAS, BRAF, MEK and ERK. Within the EAP, investigators will track patients’ response, adverse events, tolerability, and quality of life on ulixertinib.

Early data on the drug has shown ulixertinib may have activity against cancers with alterations in these genes, particularly tumors with BRAF aberrations other than V600 mutations, for which there are currently no approved drugs.

BioMed Valley, a clinical stage biotech firm, announced over the summer that the National Cancer Institute’s MATCH trial would include arms where adult and pediatric cancer patients with certain tumor markers could receive ulixertinib.

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