Novartis gets CDSCO panel nod to study anticancer drug JDQ443

Written by Dr. Divya Colin Published On 2022-12-17T18:00:28+05:30 | Updated On 20 Dec 2022 4:11 PM IST

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New Delhi: Pharmaceutical major Novartis, has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the study of the anti-cancer JDQ443, an investigational selective, covalent, and orally bioavailable KRASG12C inhibitor.

However, the approval is subject to a condition that the firm should update safety and efficacy data from ongoing Phase IIb/II study and to report all death irrespective of its cause i.e., PD as SAE to CDSCO as per NDCTR 2019.

This came after the drug major Novartis presented Phase III clinical trial protocol no CJDQ44B12301, KontRASt-02, before the committee.

JDQ443 is an investigational selective, covalent, and orally bioavailable KRASG12C inhibitor.

KRAS mutations are the most frequent oncogenic drivers in non-small cell lung cancer (NSCLC), the most common type of lung cancer. The most common form of KRAS mutation is G12C4. JDQ443 inhibits this mutated form of KRAS in a structurally distinct way, trapping KRAS G12C in a GDP-bound, inactive state while avoiding direct interaction with H95, a recognized route for resistance. In preclinical models, JDQ443 potently inhibited KRAS G12C cellular signalling and proliferation in a mutant-selective manner and demonstrated dose-dependent antitumor activity

At the recent SEC meeting for Oncology and Hematology held on December 9th, 2022, the expert panel reviewed the Phase III clinical trial (protocol no CJDQ44B12301, KontRASt-02) of the anti-cancer drug JDQ443

After detailed deliberation, the committee recommended for grant of permission to conduct the study with following conditions-

1. The applicant should submit updated safety and efficacy data from ongoing Phase Ib/II study before the committee for review.

2. The applicant and investigators should report all death irrespective of its cause i.e.PD as SAE to CDSCO as per NDCTR 2019 during the conduct of the study.

Also Read:Roche Gets CDSCO Panel Nod To study Ophthalmic Drug Faricimab

CJDQ443novartisCDSCOnovartis newsCentral Drug Standard Control Organizationnon small cell lung cancerlung cancercancer drug

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.