AstraZeneca files cancer drugs in US and EU
AstraZeneca (AZ) has begun the second quarter on the front foot with a filing for a potential first-in-class cancer drug in the US, and an application to expand the use of its ovarian cancer drug Lynparza in Europe.
AZ, and its biologics research unit Medimmune, said the FDA accepted a filing for moxetumomab pasudotox, an immunotoxin targeting CD-22, for adults with hairy cell leukaemia (HCL) who have received at least two prior lines of therapy.
The FDA has granted a six-month Priority Review, as opposed to the standard 10-month period, and a decision is due in the third quarter.
AZ’s dossier is based on a phase 3 trial that met its primary endpoint of durable complete response in adults with relapsed or refractory HCL.
There is currently no established standard of care and few treatments available – and the FDA has granted the faster review because the drug could offer a significant improvement, either in safety or effectiveness, over existing therapies.
Immunotoxins are a class of anticancer agents that combine a cancer-seeking antibody with a toxic payload that kills malignant cells.
Moxetumomab pasudotox is composed of a binding portion of an anti-CD22 antibody fused to a toxin.
The drug binds to CD22, a protein that is overexpressed on the surface of HCL cells, and then delivers the toxin payload inside the cancer cell, leading to cell death.
EU breast cancer use for Lynparza?
In a separate development AZ and partner Merck & Co, known as MSD outside the US, have applied for a new use for their cancer drug Lynparza (olaparib) in breast cancer in the EU.
Lynparza was the first poly (ADP ribose) polymerase (PARP) inhibitor drug approved in Europe in 2015, as a maintenance treatment for certain ovarian cancer patients with BRCA mutations.
But since then several competitors have made it to market – Clovis Rubraca (rucaparib) and Tesaro’s Zejula (niraparib).
The FDA approved Lynparza in metastatic breast cancer with BRCA mutations in January, and the companies hope for a repeat performance in Europe.
The EU filing is for patients with deleterious or suspected deleterious BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
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