CDSCO Panel Approves Eli Lilly's Protocol Amendment proposal to study Anti-cancer Drug LY3537982
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by the drug major Eli Lilly for the investigational anticancer LY3537982 study.
This came after the firm presented protocol amendment (f) dated 22-Aug- 2024 and Protocol Addendum (6) dated 14-Nov-2024 protocol no. J3M-MC-JZQB.
This is a global pivotal study in participants with KRAS G12C-Mutant, locally advanced or metastatic non-small cell lung cancer, comparing first-line treatment of LY3537982 and Pembrolizumab vs. Placebo and Pembrolizumab in those with PD-L1 expression >=50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs. Placebo and Pembrolizumab, Pemetrexed, Platinum regardless of PD-L1 expression.
LY3537982, a highly selective, potent KRAS G12C inhibitor, demonstrated preliminary efficacy and tolerability in patients with KRAS G12C-mutated solid tumors. LY3537982 has unique pharmacological properties that allow it to achieve high target occupancy at low exposures. This allows it to be combined with other agents more safely. In preclinical models, LY3537982 has shown activity as monotherapy and in combination with other anticancer therapies.
Olomorasib is a promising new drug that targets the KRAS G12C mutation, offering a novel approach to treating cancers such as NSCLC and colorectal cancer. Its mechanism of action involves selectively inhibiting the mutant KRAS protein, thereby disrupting cancer cell proliferation and promoting apoptosis.
At the recent SEC meeting for Oncology held on 18th and 19th December 2024, the expert panel reviewed the protocol amendment (f) dated 22-Aug-2024 and Protocol Addendum (6) dated 14-Nov-2024 protocol no.J3M-MC-JZQB.
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.
