Janssen Korea highlights ‘Rybrevant 바카라사이트 소울카지노’ as best option for rapid introduction and accessibility in Korea

[by Yu, Suin] Janssen Korea is accelerating efforts to introduce the subcutaneous injection (SC) formulation of the lung cancer treatment ‘Rybrevant (amivantamab)’ into the Korean market. This initiative aims to strengthen the company’s competitive position by leveraging synergies with Yuhan Corporation’s oral anticancer drug ‘Leclaza’ (lazertinib, marketed in the U.S. and Europe as Lazcluze) used as a combination therapy.

Janssen Korea, the Korean pharmaceutical division of multinational pharmaceutical company Johnson & Johnson (J&J), announced on June 11, “We are fully committed to quickly bringing the 바카라사이트 소울카지노 formulation of Rybrevant to the market,” and added, “We are carefully reviewing the matter, taking into account a variety of factors, including the current global market environment and the situation in the United States.”

바카라사이트 소울카지노 is a bispecific antibody that simultaneously targets the ‘epithelial growth factor receptor (EGFR)’ and the ‘mesenchymal epithelial transition factor (MET)’. J&J is actively working to expand its indications and extend its presence in international markets through a combination therapy with Leclaza, a drug licensed from Yuhan Corporation in 2018. 바카라사이트 소울카지노 has secured regulatory approvals in the U.S., Europe, the United Kingdom, Canada, Korea, and Japan. Notably, in January, Korea’s Ministry of Food and Drug Safety approved it as a ‘first-line treatment for non-small cell lung cancer.’

Previously, regulatory approval was granted for the intravenous (IV) formulation. However, J&J aims to establish a dominant position in the first-line treatment market for non-small cell lung cancer by offering the ‘Rybrevant 바카라사이트 소울카지노 + Leclaza’ combination therapy in the future. In terms of therapeutic efficacy, this combination has been clinically shown to be significantly more effective than the current first-line treatment, AstraZeneca’s monotherapy ‘Tagrisso (osimertinib).’ J&J plans to further expand its market share by improving administrative convenience and other factors.

In Europe, the subcutaneous (바카라사이트 소울카지노) formulation of Rybrevant received approval from the European Commission (EC) in April, and J&J is currently working toward obtaining product approval in the United States. At the end of 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Rybrevant 바카라사이트 소울카지노 formulation.

The IV formulation offers the advantage of rapid systemic body distribution, yet it requires administration under medical supervision, necessitating hospital visits and injection times exceeding 2-3 hours. Conversely, the 바카라사이트 소울카지노 formulation provides advantages in administration convenience, as it can be administered within a few minutes. This convenience is further amplified by the fact that Leclaza, the combination drug of Rybrevant, is an oral formulation, thereby substantially reducing the overall administration time for the combination therapy.

Furthermore, the Rybrevant 바카라사이트 소울카지노 formulation demonstrates superior efficacy in terms of side effects, such as ‘infusion-related reactions (IRR),’ when compared to the IV formulation. According to data from the Phase 3 clinical trial (PALOMA-3) of the ‘Rybrevant 바카라사이트 소울카지노 + Leclaza’ combination therapy presented at the American Society of Clinical Oncology (A바카라사이트 소울카지노O) last year, the administration time for the Rybrevant 바카라사이트 소울카지노 formulation was markedly reduced to approximately 5 minutes, a substantial decrease from the initial IV administration time (approximately 5 hours over two days). Moreover, the IRR incidence rate decreased by more than fivefold (13% for subcutaneous injection vs. 66% for intravenous injection).

Additionally, the Rybrevant 바카라사이트 소울카지노 formulation demonstrated non-inferiority compared to the IV formulation, meeting the criteria for two key pharmacokinetic (PK) indicators. Regarding the secondary endpoint, objective response rate (ORR), the 바카라사이트 소울카지노 formulation group achieved 30% (95% confidence interval [CI]: 24–37), while the IV formulation group showed 33% (95% CI: 26–39).

“The 바카라사이트 소울카지노 formulation offers improved safety in terms of side effects compared to the IV formulation and can significantly shorten the administration time,” said Professor Kang Jin-hyung of the Department of Oncology at the Catholic University of Korea, Seoul St. Mary’s Hospital. “Based on the clinical data published to date, provided there are no cost differences in administration, there is no reason for medical professionals to avoid using the 바카라사이트 소울카지노 formulation.”

In addition, transitioning to the 바카라사이트 소울카지노 formulation can also serve to extend the patent protection of existing anticancer treatments. In line with this, MSD (Merck, USA), the developer of the world’s No. 1 anticancer drug, ‘Keytruda (pembrolizumab)’, is actively pursuing a formulation conversion. The company has already filed applications for product approval of the Keytruda 바카라사이트 소울카지노 formulation with the FDA and Korea’s Ministry of Food and Drug Safety. “We completed the application for product approval for the Keytruda 바카라사이트 소울카지노 formulation in Korea this March,” announced MSD Korea, the domestic affiliate of MSD.