Yuhan Corporation's lung cancer drug 'Lazrada (ingredient name: Raizatinib)' has received sales approval from Japanese health authorities for combination therapy. Following the U.S., Europe, and the United Kingdom, it aims to penetrate the Japanese market in combination with Johnson & Johnson's 'Librevant (ingredient name: Amivantamab).
Johnson & Johnson noted that the combination therapy of 'Lazrada (domestic product name: Lazrada)' and Librevant has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) as a treatment for progressive or recurrent unresectable epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) as of 27th (local time).
The Lazrada and Librevant combination therapy is expected to be used for patients with non-small cell lung cancer who have failed EGFR inhibitor treatment as a result of this approval. The combination therapy was approved in Europe in December following U.S. Food and Drug Administration (FDA) approval last August, and in the United Kingdom on the 6th of this month. Approval in China is also pending.
With the Japanese approval, Yuhan Corporation's milestones (tiered royalties) will also increase. Yuhan Corporation received a milestone of $60 million (approximately 8 billion won) from the U.S. approval last September. The milestone to be received from the European approval is $30 million (approximately 4 billion won). With this Japanese approval, it is expected to receive a milestone of 22 billion won.
The Lazrada and Librevant combination therapy showed an overall survival duration (OS) extension of over one year in a Phase 3 clinical trial (MARIPOSA) compared with AstraZeneca's Tagrisso, which had been used as a standard treatment for lung cancer. Tagrisso's overall survival duration is 36.7 months, while Lazrada is expected to enable survival of over 4 years.