AstraZeneca cancer drug gets first Japan approval

Bloomberg

AstraZeneca Plc’s new drug Imjudo won approval in Japan for two different cancer types when added to the blockbuster medicine Imfinzi, widening the immune therapy’s reach.
The treatment, a monoclonal antibody, is now authorised for forms of lung and liver cancer in Japan for patients who are also receiving Imfinzi, Astra said.
The approval, coming after clearance in the US and a positive recommendation in Europe, is another step forward in Chief Executive Officer Pascal Soriot’s effort to deepen the UK drugmaker’s presence in the cancer field.
Imjudo’s progress in Japan brings the first dual immune-therapy regimen to patients in the country, Astra said. The drug won its first approval in October, when US regulators cleared it for the most common type of liver cancer.
Earlier this month, European regulators recommended authorising Imjudo for patients with that form of liver cancer, saying the combination with Imfinzi marked a “significant improvement in overall survival compared with the standard of care.”
Imjudo, like Imfinzi, belongs to a class of medicines called checkpoint inhibitors.
Astra is testing the combination across other tumor types including bladder cancer, the company said.
Imfinzi is one of Astra’s leading cancer drugs, with sales of about $2 billion through September, the company said last month.