Healthcare products company Johnson & Johnson (J&J) (NYSE:JNJ) announced on Tuesday that it has received US Food and Drug Administration (FDA) approval for RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) as a first-line treatment for patients with EGFR-mutated advanced lung cancer.
This combination therapy is the first chemotherapy-free regimen to demonstrate superior progression-free survival compared to osimertinib.
The approval is based on data from the Phase 3 MARIPOSA study, which showed a 30% reduced risk of disease progression or death with RYBREVANT plus LAZCLUZE versus osimertinib. The combination also extended median duration of response by nine months.
Lung cancer is a leading cause of cancer deaths globally. Of patients with EGFR-mutated non-small cell lung cancer (NSCLC), 25-39% never receive second-line therapy due to disease progression and lack of treatment options.
Mabwell's B7-H3-targeting ADC clinical trial application receives Chinese regulatory approval
Dupixent receives approval in Japan as first biologic for COPD treatment
Vast Therapeutics' ALX1 drug candidate granted QIDP designation by US FDA
Actinium Pharmaceuticals signs Ac-225 radioisotope agreement with Eckert & Ziegler
GSK's Nucala (Mepolizumab) COPD application accepted by EMA
Everest Medicines' EVM14 IND application receives US FDA approval
Clover Biopharmaceuticals' SCB-1019 IND application receives US FDA approval
CStone Pharmaceuticals submits Type II variation application to EMA for sugemalimab
Hikma announces Health Canada approval of KLOXXADO Nasal Spray for opioid overdose treatment
Johnson & Johnson reports breakthrough overall survival data for EGFR-mutated lung cancer treatment
Altesa BioSciences granted US regulatory approval for vapendavir clinical trials
Black Diamond Therapeutics and Servier agree global licensing deal for BDTX-4933
AstraZeneca secures EU approval for Imfinzi in limited-stage small cell lung cancer