The CEO of U.S. pharmaceutical company Johnson & Johnson (J&J) emphasized the potential of "Recrazar," the first domestic cancer drug.
Joaquín Duato, J&J CEO, noted during the 43rd JP Morgan Healthcare Conference in San Francisco at the Westin St. Francis Hotel on the 13th (local time) that "the combination therapy of Recrazar and Librevant is an underappreciated drug in the market."
Recrazar (ingredient name Rayizatinib) is a domestic cancer drug that was transferred in technology to J&J subsidiary Janssen for 1.4 trillion won in 2018. It was approved as a first-line treatment for non-small cell lung cancer by the U.S. Food and Drug Administration (FDA) in August of last year through combination therapy with Janssen's lung cancer treatment, Librevant (Amivantamab).
Janssen's Librevant targets both the epidermal growth factor receptor (EGFR) and the hepatocyte growth factor receptor (MET) simultaneously. Both EGFR and MET are involved in cell growth of solid tumors, aiding in the proliferation and growth of cancer cells.
Recrazar obstructs the signaling of EGFR and MET through combination therapy with Librevant, preventing the proliferation of lung cancer cells. The most common genetic mutation in non-small cell lung cancer patients is the EGFR mutation. Lung cancer with EGFR mutation has a five-year survival rate of less than 20%. It is particularly more frequent among Asian non-smokers. This is the reason Recrazar is being considered as a new treatment for these EGFR patients.
Duato emphasized that the combination therapy of Recrazar and Librevant has shown higher efficacy than existing therapies. He stated, "The combination therapy with Librevant has shown a result of extending the survival period of lung cancer patients with a life expectancy of three years by more than one year," adding, "This is a change that will alter the treatment paradigm."
The standard treatment for non-small cell lung cancer patients with EGFR mutation is AstraZeneca's Tagrisso (Osimertinib) from the United Kingdom, which has a median overall survival (mOS) of about three years, but it is expected that the combination therapy of Recrazar and Librevant will extend this to over four years. J&J anticipates annual sales targets of over 7 trillion won for the combination therapy of Recrazar and Librevant.
J&J has submitted a request to the FDA for approval to administer Librevant, which currently comes in intravenous (IV) form, as a subcutaneous injection (SC). If approved, the chemotherapy administration time, which currently takes more than five hours, will be reduced to just under five minutes. This could significantly increase the chances of Recrazar becoming a "blockbuster" new drug with annual sales exceeding $1 billion.
Duato stated, "The review for the subcutaneous injection formulation is currently underway, and if approved, the combination therapy with Librevant will eventually become the standard for first-line treatment," and added, "We will conduct Phase 3 clinical trials targeting head and neck cancer and colorectal cancer patients with EGFR mutation."