J&J Gains FDA Approval for Combination Therapy with Livibrant
First FDA Approval Case for Domestic Anticancer Drug
Reduces Risk by 30% Compared to 'Standard Treatment' Tagrisso
US Launch Expected Within the Year... J&J Expects Over 7 Trillion KRW Annual Sales from Combination Therapy
Yuhan Corporation's new lung cancer treatment drug, Lekraza, has rewritten the history of anticancer drug development. It is the first cancer treatment developed domestically to receive approval from the U.S. Food and Drug Administration (FDA).
Johnson & Johnson (J&J) announced on the 20th (local time) that the combination therapy of Lekraza (U.S. name: Razcluze) and Rybrevant has been approved by the FDA as a first-line treatment for patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations. J&J explained the significance by stating, "The combination therapy of Lekraza and Rybrevant is the first and only multi-targeted, chemotherapy-free combination therapy proven to be superior to Tagrisso, which is approved as a first-line treatment for EGFR-mutated lung cancer patients."
J&J plans to launch the Lekraza-Rybrevant combination therapy in the U.S. market within this year. J&J acquired the rights to Lekraza in December 2018 for $1.255 billion (approximately 1.7 trillion KRW) and expects the combination therapy to grow into a blockbuster generating annual sales of $5 billion (approximately 6.7725 trillion KRW). Yuhan Corporation is also expected to receive a milestone payment of around 80 billion KRW from this approval. Once product sales begin in earnest, Yuhan will also receive at least a 10% royalty on sales. Lekraza monotherapy has been expanding its market since January, with health insurance coverage applied for its use as a first-line drug treatment for lung cancer patients in Korea.
Notably, this approval marks the first case of a cancer treatment developed in Korea receiving FDA approval, sending a strong message to the domestic pharmaceutical and biotech industries. Previously, Hanmi Pharmaceutical’s Rolontis was approved, but it is a drug that treats side effects of anticancer therapy rather than the cancer itself. HLB’s Rivoceranib attempted to challenge the market before Lekraza but failed and is currently preparing for a re-challenge.
Lung cancer is one of the leading causes of cancer deaths worldwide, with 1.8 million deaths annually. Among these, 80-85% are known to be due to non-small cell lung cancer. Cancer cells mutate in various ways to evade the patient’s immune system, with EGFR mutations being a representative mutation in lung cancer. Up to 15% of Western lung cancer patients and about 40% of Asian patients exhibit EGFR mutations. Lekraza and AstraZeneca (AZ)’s Tagrisso were developed as targeted anticancer drugs that specifically seek and kill EGFR-mutated cancer cells.
This approval was based on the 'Mariposa' clinical trial results revealed at the European Society for Medical Oncology (ESMO) conference last October. In this trial, the combination therapy of Lekraza and Rybrevant reduced the risk of disease progression or death by 30% compared to AZ’s Tagrisso, the current standard treatment for EGFR-mutated lung cancer. The median progression-free survival (PFS), a key indicator of anticancer drug efficacy, was 23.7 months, showing improvement compared to 16.6 months for patients taking only Tagrisso.
J&J and Yuhan Corporation expect this therapy to become the best-in-class drug within its category, having confirmed results surpassing the existing standard treatment, Tagrisso, in clinical trials. The combination therapy is anticipated to show even better efficacy in some high-risk patients, such as those with brain or liver metastases or other special mutations, in addition to typical EGFR mutation patients.
Jennifer Taubert, Vice President of J&J’s Pharmaceutical Division, said, “Based on over 30 years of oncology innovation, we are uniquely positioned to develop best-in-class treatments in areas where survival rates have stagnated for years. The combination therapy of Rybrevant and Lekraza has established a new standard in the treatment of advanced first-line therapy and we hope to provide patients with a new treatment option without chemotherapy.”
Jo Wook-je, CEO of Yuhan Corporation, stated, “The FDA approval of Lekraza is a meaningful result of Yuhan’s research and development (R&D) investment through open innovation.” He added, “We hope this approval will not be the end point but a milestone, laying the foundation for launching globally innovative new drugs representing Korea and achieving Yuhan’s goal of becoming a global top 50 pharmaceutical company through continued R&D investment.”
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