The next-generation EGFR-TKI’Lecrajajeong (ingredient name Razertinib)’ developed by Yuhan Corporation has obtained conditional approval from the Ministry of Food and Drug Safety.
On the 18th, the Ministry of Food and Drug Safety approved Yuhan Corporation’s non-small cell lung cancer treatment’Recrajajeong’ as the 31st new drug developed in Korea.
‘Recrazaze’ is a targeted anticancer drug that inhibits the proliferation and growth of lung cancer cells by interfering with the signal transduction involved in lung cancer cell growth. Permitted for use in patient treatment.
When EGFR-TKI is used for the primary treatment of advanced EGFR mutation-positive non-small cell lung cancer, it is known that the acquired resistance mutation’T790M mutation’ occurs in half of patients.
Therefore, there is a medically unsatisfied demand for various treatment options that can treat the T790M mutant patient group.
To date,’Tagriso’, developed by global pharmaceutical company AstraZeneca, is the only treatment that has proven effective in EGFR T790M mutant patients. However, it has been pointed out among domestic lung cancer experts that this drug is in need of improvement due to poor patient access due to its high price.
The approval of the Ministry of Food and Drug Safety for’Lecra Midnight’ is a’conditional approval’ that is conditional on conducting a phase 3 clinical trial after marketing. Yuhan Corporation applied for permission based on the results of a phase 2 clinical trial conducted in Korea.
The Ministry of Food and Drug Safety said, “The quality, safety and effectiveness, and post-marketing safety management plans for the applied drugs were thoroughly scientifically reviewed and evaluated according to the review criteria of the’Pharmaceutical Affairs Act. The included central pharmacy review committee consulted on the completion of the permit and conformity to the system,” he explained.
“Through this new drug approval, we expect that the range of drug selection for the treatment of patients with recurrent non-small cell lung cancer can be expanded.” I will try to supply a treatment with a sufficiently confirmed surname.’