Regulatory Affairs

US and European regulators accept AstraZeneca’s applications for cancer treatments

PBR Staff Writer Published 04 April 2018

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted AstraZeneca’s applications for cancer treatments moxetumomab pasudotox and Lynparza (olaparib).

The FDA has accepted AstraZeneca and MedImmune’s biologics license application (BLA) for moxetumomab pasudotox, which is an investigational anti-CD22 recombinant immunotoxin and potential new medicine to treat adult patients with hairy cell leukaemia (HCL) who have received at least two prior lines of therapy.

Moxetumomab pasudotox’s 1053 phase III clinical study achieved its primary endpoint of durable complete response in adult patients with relapsed or refractory HCL.

The 1053 trial is a single-arm and multicentre Phase III clinical trial evaluating the efficacy, safety, immunogenicity and pharmacokinetics of moxetumomab pasudotox monotherapy in patients with relapsed or refractory HCL who have received at least two prior therapies.

The trial recruited 80 patients across 34 sites in 14 countries.

The EMA has accepted AstraZeneca and Merck’s marketing authorization application (MAA) for review of Lynparza to treat 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.

Both firms have submitted application for Lynparza based on data from the randomized and open-label phase III OlympiAD trial, which studied Lynparza against chemotherapy (physician’s choice of capecitabine, eribulin or vinorelbine).

The trial recruited 302 patients, of which 205 patients were randomised to receive Lynparza and 97 patients were randomised to receive chemotherapy.

Patients in the OlympiAD trial had germline BRCA-mutated, HER2-negative (hormone receptor-positive or triple negative) breast cancer, and secured Lynparza for treatment in the metastatic setting.

According to AstraZeneca, the Lynparza significantly prolonged progression-free survival compared with chemotherapy and reduced the risk of disease progression or death by 42% in the study.

In January this year, the FDA approved Lynparza to treat BRCA-mutated HER2-negative metastatic breast cancer.


Image: The US FDA and EMA have accepted AstraZeneca’s applications for cancer treatments moxetumomab pasudotox and Lynparza. Photo: courtesy of AstraZeneca.