HLB Reapply for Liver Cancer Drug Approval from FDA

On 16 May this year, the FDA issued a Complete Response Letter (CRL) requesting additional information on the Chemistry, Manufacturing, and Controls (CMC) section of camrelizumab after reviewing the combination therapy of “rivoceranib + camrelizumab.” This prompted HLB’s US subsidiary, Elevar Therapeutics, and its partner, Hansoh Pharmaceutical, to take swift action to address the FDA’s concerns.

Hansoh Pharmaceutical found the FDA’s comments to be manageable and made sufficient efforts to demonstrate the completeness of the CMC since the CRL. They quickly proved there were no issues with the drug’s manufacturing. The FDA recommended submitting all documents without any further requests for additional information.

On September 20 (U.S. time), Elevar Therapeutics and Hansoh Pharmaceutical completed the submission of the re-evaluation application for liver cancer drug approval. This submission was completed approximately four months after receiving the CRL, putting the new drug approval process back on track. The submitted documents included data on the longest patient survival period (mOS 23.8 months) presented at the American Society of Clinical Oncology (ASCO 2024).

The FDA, which received the documents, will set a review period and notify the company within a month. Depending on the FDA’s classification criteria, if it is Class 1, the approval decision will be made within two months from the submission date, and if it is Class 2, within six months. Therefore, if the review proceeds smoothly, the new drug could be approved as early as November 20 or by March 20 at the latest.

Elevar CEO Jung Se-ho stated, “We are pleased to have been able to submit the re-evaluation application within the promised period based on the active cooperation of both companies,” adding, “As the company is confident in the approval, we will proceed with the production of the new drug and large-scale marketing preparations in the U.S. according to the set schedule without any setbacks.”

The FDA’s request for additional information was solely focused on the CMC section of camrelizumab, with no comments on the efficacy or safety of the new drug. Hansoh Pharmaceutical commented, “The FDA’s comments were manageable and we made sufficient efforts to demonstrate the completeness of the CMC since the CRL.”

Understanding the context of this event requires knowledge of the FDA drug approval process, including the significance of a CRL and the role of CMC in drug evaluation. Liver cancer, a prevalent and serious condition, necessitates new and effective treatment options, making the development of combination therapies like “rivoceranib + camrelizumab” crucial. Clinical trials and data, such as the median overall survival (mOS) presented at ASCO, play a vital role in demonstrating a drug’s efficacy.