Dual FDA Approval Hopes for Camrelizumab and Lenvatinib... "Decision by May Next Year"

HLB's Review of Riboceranib Begins
Camrelizumab Also Enters Review
Both Expected to Have Results in May per PDUFA

Combination Therapy First to Exceed 20 Months mOS in Liver Cancer

Hengrui Pharmaceuticals' immune checkpoint inhibitor 'Camrelizumab' combination therapy has entered the full review stage for the U.S. Food and Drug Administration (FDA) Biologics License Application (BLA). With the decision expected by May next year, attention is also focused on CG Inbites (formerly Crystal Genomics), which holds the domestic rights.

CG Invites (formerly Crystal Genomics) logo [Photo by CG Invites]

According to Hengrui Pharmaceuticals, CG Inbites announced on the 1st that it received notification from the FDA the day before regarding the initiation of the BLA review for Camrelizumab combination therapy as a first-line treatment for hepatocellular carcinoma. The Prescription Drug User Fee Act (PDUFA) target date for the final approval decision is set for May 31 next year (local time).

Camrelizumab demonstrated efficacy by surpassing 20 months for the first time ever, with a median overall survival (mOS) of 22.1 months in a Phase 3 combination clinical trial with 'Apatinib' presented at last year's European Society for Medical Oncology (ESMO). In contrast, the mOS for the control group receiving 'Sorafenib' monotherapy was only 15.2 months. Other key indicators such as median progression-free survival (mPFS) and objective response rate (ORR) also showed superiority: mPFS was 5.6 months compared to 3.7 months in the control group, and ORR was 25.4% versus 5.9% in the control group.

When analyzed by major causes of hepatocellular carcinoma, significant survival benefits were observed in patients with hepatitis B virus (HBV), which is more prevalent among East Asians, and hepatitis C virus (HCV), which is more common among Western populations, confirming the treatment's effectiveness regardless of region or etiology.

Apatinib refers to HLB's liver cancer drug 'Lenvatinib.' Originally developed under the name Apatinib, the ingredient name was changed to Lenvatinib in 2018 to avoid confusion with another lung cancer drug with a similar name. However, the name Apatinib is still commonly used in China.

Lenvatinib also received notification from the FDA on the 14th that its full review has begun. HLB expects the approval decision under PDUFA to be made by May 16 next year. Unlike Camrelizumab, which is undergoing BLA as a biologic drug, Lenvatinib is proceeding with a New Drug Application (NDA) as a synthetic drug.

The combination therapy of programmed cell death protein 1 (PD-1) inhibitor immune checkpoint inhibitor Camrelizumab and the tyrosine kinase inhibitor (TKI) class oral drug Lenvatinib, which inhibits vascular endothelial growth factor receptor (VEGFR)-2, works by modifying tumor endothelium through anti-angiogenic agents to improve drug delivery, thereby increasing infiltration of effector immune cells.

In China, the combination therapy of these two drugs for liver cancer was already approved as a first-line treatment in February. This is described as the first combination of a TKI inhibitor and an immune checkpoint inhibitor. Currently, the first-line treatment market for liver cancer recommends only the combination therapy of PD-L1 inhibitor 'Atezolizumab' and VEGFR inhibitor 'Bevacizumab' or Sorafenib monotherapy.

Meanwhile, Camrelizumab recorded sales of $1.7 billion (approximately 2.19 trillion KRW) last year, with expectations to grow to $2.793 billion (approximately 3.6 trillion KRW) by 2026.

A CG Inbites official stated, “Camrelizumab has currently obtained approval from the Korean Ministry of Food and Drug Safety for clinical trial plans for sales purposes targeting non-small cell lung cancer, and bridging clinical trials are underway. Through the initiation of the FDA full review, we plan to actively consider expanding clinical trials in Korea as well.”

This content was produced with the assistance of AI translation services.