FDA Announces Regulatory Review Period for JAYPIRCA for Patent Extension Consideration
May 10, 2025
May 10, 2025
WASHINGTON, May 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has determined the regulatory review period for JAYPIRCA, a human drug product, for the purpose of patent extension.
JAYPIRCA, developed by Loxo Oncology, Inc., is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, who have undergone at least two lines of systemic therapy, including a Bruton tyrosine kinase inhibitor. The pro . . .
JAYPIRCA, developed by Loxo Oncology, Inc., is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, who have undergone at least two lines of systemic therapy, including a Bruton tyrosine kinase inhibitor. The pro . . .