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FDA Grants Fast Track Designation to Novel Treatment in Breast Cancer
The FDA granted Fast Track Designation to CX-5461, a first-in-class G-quadruplex stabilizer, for the treatment of patients with breast and ovarian cancers BRCA1/2, PALB2, or other HRD mutations.
CX-5461 stabilizes the DNA G-quadruplexes of cancer cells, causing a disruption in the cell's replication fork, according to a press release from the manufacturer.
In BRCA1/2 mutations, it acts in tandem with Homologous Recombination pathway deficiencies, replication forks stall and cause DNA breaks, resulting in cancer cell death.
In a phase 1 trial, the drug showed clinically significant and lasting benefits in patients with BRCA1/2 and PALB2 mutations, as well as in patients resistant to platinum and other chemotherapeutics.
A phase 1b expansion study is ongoing to determine a tolerable dose in patients with selected solid tumors, including breast, ovarian, pancreatic, and prostate cancer, with BRCA2 and PALB2, and ovarian cancer with BRCA1 and other HR gene mutations.
The dosing amount will be used in future phase 2 trials.
Reference:
https://www.prnewswire.com/news-releases/senhwas-pidnarulex-receives-us-fda-fast-track-designation-for-the-treatment-of-solid-tumors-with-brca12-palb2-and-other-hr-gene-mutations-301467006.html
Images: Getty Images, Pixabay
By Alexa Josaphouitch, Staff Writer