What is the story about?
What's Happening?
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced that its new drug application for the RET kinase inhibitor A400, also known as EP0031, has been accepted for review by China's National Medical Products Administration (NMPA). This drug is intended for the treatment of adult patients with RET-fusion positive non-small cell lung cancer (NSCLC). The acceptance is based on positive results from Phase 2 cohorts of the KL400-I/II-01 study, which demonstrated favorable efficacy and a manageable safety profile in pre-treated and treatment-naïve NSCLC patients. The drug has shown promise in addressing acquired drug-resistant mutations and safety issues such as hypertension and hematological toxicity.
Why It's Important?
The acceptance of A400/EP0031 for review is significant as it represents a potential advancement in the treatment of RET-fusion positive NSCLC, a condition with limited treatment options. The drug's ability to target RET mutations could offer improved outcomes for patients who do not benefit from conventional therapies. This development highlights the ongoing innovation in cancer treatment, particularly in precision medicine, and could lead to better management of NSCLC, impacting patient care and treatment protocols globally.
What's Next?
Kelun-Biotech is working closely with regulatory authorities to expedite the review process for A400/EP0031. The company aims to bring this innovative therapy to patients as soon as possible. Additionally, the drug has been granted Fast Track designation by the FDA for the treatment of RET-fusion positive NSCLC, and Phase 2 clinical development is underway in multiple countries, including the United States.
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