Pharma Focus Asia

Golidocitinib Receives Approval in China as the First JAK1-Selective Inhibitor for Treating Relapsed or Refractory Peripheral T-Cell Lymphoma

Thursday, June 20, 2024

Dizal (SSE:688192), a biopharmaceutical company dedicated to developing new treatments for cancer and immunological diseases, announced that golidocitinib has received approval from the National Medical Products Administration of China. This approval allows its use in adult patients suffering from relapsed or refractory peripheral T-cell lymphoma (PTCL) who have not responded to at least one prior systemic therapy. This makes golidocitinib the first and only globally approved selective Janus kinase 1 (JAK1) inhibitor specifically for this patient group.

PTCL is a challenging group of aggressive lymphomas originating from T-cells and natural killer cells. Patients with PTCL often face high rates of disease recurrence even after initial remission from conventional treatments. Those with relapsed or refractory PTCL have a poor prognosis, with a 3-year survival rate of 23% and a median survival of about 5.8 months. While some drugs have been conditionally approved for this condition, their effectiveness as monotherapies has been limited, with objective response rates typically under 30%.

The approval of golidocitinib is supported by the results of the JACKPOT8 Part B study, a key international trial that assessed its efficacy and safety as a monotherapy in r/r PTCL patients. The primary endpoint, evaluated by an independent review committee, showed significant and sustained antitumor effects with a favorable safety profile compared to existing treatments. Data from this study, published in The Lancet Oncology and presented at the 65th American Society of Hematology Annual Meeting, revealed that golidocitinib achieved an objective response rate of 44.3%, including a complete response rate of 23.9%, with responses across various PTCL subtypes. The median duration of response was 20.7 months, with over half of the patients continuing to respond.

"Golidocitinib's innovative mechanism and unique molecular design establish it as the first oral JAK1-selective inhibitor for r/r PTCL," said Dr. Jun Zhu, the principal investigator for the JACKPOT8B study at the Department of Lymphoma, Peking University Cancer Hospital and Institute. "The approval of golidocitinib offers a valuable new treatment option for PTCL patients."

Dizal has been a pioneer in targeting the JAK/STAT pathway for PTCL therapy, developing golidocitinib as the first JAK1-specific inhibitor with significant selectivity over other JAK family members and favorable pharmacokinetic properties.

"We are excited to bring golidocitinib to patients in China, marking the second innovative drug approved by Dizal," stated Dr. Xiaolin Zhang, CEO of Dizal. "Golidocitinib's effectiveness across different PTCL subtypes sets it apart from other targeted therapies. At Dizal, our goal is to discover and develop groundbreaking treatments to meet significant unmet medical needs globally. The US FDA's Fast Track designation for golidocitinib highlights its potential, and we are accelerating its development to benefit patients worldwide."

Golidocitinib has garnered attention at various international conferences, including ASCO, EHA, ICML, and ASH, with six oral presentations over four years. The findings from the multinational JACKPOT8 study have been published in Annals of Oncology and The Lancet Oncology.

Golidocitinib is currently the only JAK1-selective inhibitor being studied for treating r/r PTCL. It was approved by the National Medical Products Administration in China in June 2024, demonstrating robust anti-tumor efficacy with an objective response rate of 44.3% and a complete response rate of 23.9% as of August 31, 2023. The median duration of response was 20.7 months. Golidocitinib received Fast Track Designation from the US FDA in February 2022, and in September 2023, the CDE accepted its New Drug Application and granted Priority Review for the treatment of r/r PTCL. Phase I clinical data from JACKPOT8 PART A was published in Annals of Oncology, and global pivotal trial results from JACKPOT8 PART B were featured in The Lancet Oncology.

 

Source: prnewswire.com

magazine-slider-imageCytiva - Supor Prime filtersMFA + MMA 20244th Annual Cleaning Validation 20242nd Annual Pharma Impurity Conclave 2024CPHI Korea 2024CHEMICAL INDONESIA 2024World Orphan Drug Congress Europe 2024INALAB 2024Thermo Fisher - Drug Discovery and the impact of mAbsAdvanced Therapies USA 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals Conference