AstraZeneca (NASDAQ:AZN) in collaboration with its partner Merck (NYSE:MRK) has announced that their drug Lynparza has been granted expanded usage approval for prostate cancer treatment in Japan. The approval in Japan allows for the use of Lynparza (olaparib), in combination with J&J’s Zytiga (abiraterone) and prednisolone, for the treatment of adult patients suffering from BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC).

The approval by the Japanese regulatory authority was based on promising and clinically significant outcomes from a subgroup analysis of the PROpel phase III study. According to the data analysis, the combined therapy of Lynparza and Zytiga reduced the risk of disease progression or death by 77% compared to Zytiga alone, yielding a hazard ratio of 0.23. Furthermore, the combination treatment lowered the risk of death by 61% in comparison to BRCAm mCRPC patients who solely received Zytiga.

Lynparza already holds approvals for similar expanded usage in the European Union and the United States. In Japan, Lynparza is currently approved as a monotherapy for patients with BRCAm mCRPC based on the results from the Profound Study.

Throughout the year, AstraZeneca shares have experienced a 0.1% gain, contrasting with the industry’s rise of 8.1%.

AstraZeneca noted that prostate cancer ranks as the most prevalent form of cancer among men in Japan, accompanied by a high mortality rate. The existing treatment options in the region do not offer favorable prognoses for mCRPC, particularly for patients whose cancer advances after initial treatment. Consequently, an unmet medical need is evident in this context. Both AstraZeneca and Merck anticipate that the approval of the Lynparza/abiraterone combination will provide patients with an innovative treatment avenue and has the potential to establish a new standard-of-care for BRCAm mCRPC treatment.

Lynparza is presently authorized for use in Japan and other countries, including the EU and the United States, either as a monotherapy or in combination with other medications for the treatment of specific cancer types, such as ovarian, breast, prostate, and pancreatic cancers.

The collaborative development and commercialization efforts of AstraZeneca and Merck have resulted in the successful treatment of over 75,000 patients worldwide using Lynparza. Both companies are currently investigating the use of Lynparza in earlier lines of treatment for the approved cancer indications as well as exploring its potential for other cancer types. In a separate announcement, AstraZeneca revealed the approval of its rare disease drug, Soliris, in Japan for the treatment of generalized myasthenia gravis (gMG) in pediatric patients who are anti-acetylcholine receptor antibody-positive (AChR Ab+). Soliris had already secured approval for adult patients with gMG in Japan.

Following regulatory approval in Japan, Soliris became the first targeted therapy sanctioned for the treatment of children and adolescents with gMG in the country. This extension of the drug’s label is based on significant clinical improvements observed in the primary endpoint of the phase III study of Soliris in pediatric patients with refractory gMG.

Soliris also holds approvals in the European Union for expanded usage in refractory gMG among children and adolescents aged six to 17 years who are AChR Ab+. Additionally, approvals for the same indication are either in progress or scheduled in other countries.

Featured Image: Unsplash ©  Mika Baumeiste

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