MFDS approved as first-line NSCLC treatment
Pfizer’s new drug, Vizimpro, is approved for marketing in Korea. The market for EGFR inhibitors is expected to heat up.
The Ministry of Food and Drug Safety approved three different doses of Vizimpro tablets(15mg, 30mg, 45mg) on February 14th.
The MFDS recognized the drug as a effective therapy for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer(NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations.
Accordingly, Vizimpro tablets can be produced, sold and used in Korea within the scope of the MFDS‘s authorization.
Vizimpro was approved by the US Food and Drug Administration(FDA) in September 2018 and by the European Commission in April 2019.
As shown by the MFDS’s approval, Vizimpro is a targeted treatment for non-small cell lung cancer with EGFR inhibition mechanism.
EGFR is a mutated tumor gene that activates signaling pathways to grow cancer cells. Inhibition of EGFR can prevent the survival, proliferation and metastasis of cancer cells.
Such EGFR inhibitors include AstraZeneca’s Iressa(gefitinib), Roche’s Tarceva(erlotinib), Boehringer Ingelheim's Giotrif(afatinib), and AstraZeneca’s Tagrisso(osimertinib).
