The Ministry of Food and Drug Safety announced on the 5th that it has granted approval for the rare drug 'Octairo Capsule (ingredient name repotrectinib).' The importer is Korea BMS Pharmaceutical.
Repotrectinib inhibits proteins ROS1 and NTRK, which are involved in the proliferation of cancer cells, blocking cancer cell growth and survival while inducing cancer cell death for an anti-cancer effect.
There are various genetic mutations that cause lung cancer, but mutations in ROS1 and NTRK are uncommon among lung cancer patients, making anti-cancer drugs targeting these mutations rare. In this regard, the U.S. Food and Drug Administration (FDA) designated this drug as a rare drug in 2017 and subsequently classified it as an 'innovative therapy' three times.
Afterward, in 2022, the American pharmaceutical company Bristol-Myers Squibb (BMS) acquired Turning Point Therapeutics, which had been researching and developing this drug, making it a BMS treatment. This drug subsequently received FDA approval in 2023 and was launched in the U.S. in December of that year.
The Ministry of Food and Drug Safety noted, 'We expect this drug will provide new treatment opportunities for patients with ROS1-positive non-small cell lung cancer or solid tumors with NTRK gene fusions.'