Regulatory Affairs

AstraZeneca gets regulatory approvals for two cancer drugs in Japan

PBR Staff Writer Published 03 July 2018

AstraZeneca has secured regulatory approvals for two major cancer drugs, Imfinzi and Lynparza, in Japan.

AstraZeneca, along with its biologics research and development arm MedImmune, has secured approval from the Japanese ministry of health, labour and welfare for Imfinzi (durvalumab) as maintenance therapy after definitive chemoradiation therapy (CRT) in locally-advanced (stage III) and unresectable non-small cell lung cancer (NSCLC).

The approval was based on positive progression-free survival (PFS) data from the Phase III Pacific trial in unresectable stage III NSCLC.

In the trial, Imfinzi showed an improvement in median PFS of 11.2 months compared against placebo.

The pacific trial is a randomised, double-blinded, placebo-controlled and multi-centre study of Imfinzi as treatment in patients with Stage III unresectable NSCLC whose disease has not progressed following platinum-based CRT.

Imfinzi is a human monoclonal antibody, which binds to PD-L1 and stops the interaction of PD-L1 with PD-1 and CD80, helping to counter the tumour's immune-evading tactics and release inhibiting immune responses.

AstraZeneca, along with Merck, has secured approval from Japan’s pharmaceuticals and medical devices agency (PMDA) for Lynparza (olaparib) tablets for use in patients with unresectable or recurrent BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 (HER2) negative breast cancer who have received prior chemotherapy.

The approval was based on data from the randomised, open-label and phase III OlympiAD trial, which assessed against chemotherapy.

In the trial, Lynparza significantly improved progression-free survival (PFS) compared against chemotherapy and reduced the risk of disease progression or death by 42%.

OlympiAD was a randomised, open-label and multicentre phase III trial evaluating the efficacy and safety of Lynparza tablets compared against physician’s choice of chemotherapy in 302 patients with HER2-negative metastatic breast cancer with germline BRCA1 or BRCA2 mutations.

Lynparza is the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially eliminate cancer cells.

AstraZeneca oncology business unit head and executive vice president Dave Fredrickson said: “Earlier this year, Lynparza became the first PARP inhibitor available in Japan for advanced ovarian cancer. Now patients in Japan with BRCA-mutated, metastatic breast cancer will also have the opportunity to benefit from Lynparza.”


Image: AstraZeneca’s Maihara factory in Japan. Photo: courtesy of AstraZeneca.