AstraZeneca Secures Regulatory Boost for Oncology Drugs
AstraZeneca has received a double boost for its oncology portfolio after US and European regulators accepted regulatory submissions for its drugs.
The Food and Drug Administration (FDA) accepted the license application for moxetumomab pasudotox, reports the Financial Times. This medicine has the potential to treat adult patients with hairy cell leukemia (HCL) who have received at least two previous lines of treatment.
Currently, the FDA has awarded the drug “priority review” status, which is granted to medicines that, if approved, would offer a significant improvement in the treatment, diagnosis, or prevention of serious conditions.
In another decision, the European Medicines Agency accepted a regulatory submission for Lynparza, a drug which AstraZeneca now co-owns in a 50;50 partnership with Merck, to treat breast cancer that spreads elsewhere in the body for patients with a specific genetic mutation.
If approved, the drug would become the first PARP inhibitor for the treatment of breast cancer in Europe. PARP is a protein found in human cells which helps those cells to repair themselves when damaged. By stopping this repair process in cancer cells, in particular, PARP inhibitors help the cell to die.
Lynparza, became the first PARP inhibitor in January, to be approved anywhere in the world for breast cancer when it won the seal of approval from US regulators.