AstraZeneca chalks up double Japanese approval in lung and breast cancer

First up, Imfinzi (durvalumab) has been authorised as maintenance therapy after definitive chemoradiation therapy (CRT) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). The decision, taken by the Japanese Ministry of Health, Labour and Welfare, was based on Phase 3 data which showed that the drug improved median progression-free survival by 11.2 months compared to placebo, as well as overall response rates and time to distant metastasis or death.

In May earlier this year, AZ released data showing that Imfinzi had met its second primary endpoint of statistically-significant and clinically-meaningful improvement in overall survival (OS) compared to placebo. The drug is already approved in the US, Canada, India and Switzerland off the back of this data, with EU approval currently pending, expected in the second half of the year.

"Non-small cell lung cancer is a leading cause of death in Japan, and we are dedicated to bringing new treatment options to patients as quickly as possible," commented Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AZ. "As the only immunotherapy approved in the curative-intent, Stage III lung cancer setting, Imfinzi has the potential to change the treatment paradigm for patients diagnosed with this disease."

The second product to see approval is Lynparza (olaparib), which AZ is currently developing in collaboration with MSD, in the treatment of unresectable or recurrent BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 (HER2)-negative breast cancer in adult patients who have received prior chemotherapy.

The decision from the Pharmaceuticals and Medical Devices Agency (PMDA makes Lynparza the first and only PARP inhibitor approved in the country for use outside of ovarian cancer. It was based on Phase 3 data which confirmed the drug’s effectiveness, showing that it reduced the risk of disease progression or death by 42% compared to chemotherapy, while median progression-free survival stood at seven months compared to 4.2 months.

"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," added Fredrickson. "This latest approval underlines our ongoing efforts to make Lynparza available across multiple cancers as quickly as possible to patients around the world."

Dr Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer at MSD, also added: "Metastatic breast cancer is a complex disease with remaining unmet medical need. This approval is significant for breast cancer patients as the evaluation of BRCA mutations, in addition to hormone receptor and HER2 status, now becomes an important step in the management of the disease."

--------------------------------------------------------------------------------------------------------------------------------------------------

Editor's Note:

To apply for becoming a contributor of en-CPhI.Cn, 

welcome to send your CV and sample works to us, 

Email: Julia.Zhang@ubmsinoexpo.com.