ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, announced today the initiation of an expanded access program (EAP) for loncastuximab tesirine (Lonca, formerly ADCT-402) for patients in the U.S. with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The EAP is for patients who cannot be treated by currently available drugs, cell therapy, or clinical trials.
“We are pleased to offer an expanded access program for Lonca in the U.S., which will enable access to the therapy for eligible patients with relapsed or refractory DLBCL,” said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. “This program reflects ADC Therapeutics’ commitment to confronting cancer with the full potential of our science and bringing unique, targeted therapies and hope to patients and their families.”
Lonca is an investigational agent for which safety and efficacy have not yet been established. A Biologics License Application for Lonca for the treatment of relapsed or refractory DLBCL is currently under review with the U.S. Food and Drug Administration (FDA) and has been granted priority review status. The FDA has set a Prescription Drug User Fee Act target date of May 21, 2021.
To qualify for the Lonca EAP, patients with relapsed or refractory DLBCL are required to meet certain inclusion / exclusion criteria. Requests for expanded access to Lonca must be made by a licensed, treating physician in the U.S.
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