India's CDSCO Approves Two Cancer Drugs with Phase IV Trial Requirements
核心洞察
India's drug regulatory authority has approved Eli Lilly's selpercatinib tablets in multiple strengths for RET (搜索) fusion-positive non-small cell lung cancer treatment.
Intas Pharmaceuticals received approval to import and market serplulimab, a PD-1 (搜索) inhibitor monoclonal antibody for cancer treatment.
Both approvals come with mandatory Phase IV clinical trial requirements to be submitted within three months of marketing authorization.
India's Central Drug Standard Control Organization (CDSCO (搜索)) has granted approval for two significant cancer treatments, marking important additions to the country's oncology treatment landscape. The Subject Expert Committee (SEC) for Oncology approved both Eli Lilly's selpercatinib tablets and Intas Pharmaceuticals' serplulimab injection, with both companies required to conduct Phase IV clinical trials as a condition of approval.
Eli Lilly's Selpercatinib Gains Multi-Strength Approval
At the SEC meeting held on April 2, 2025, Eli Lilly received approval to import and market selpercatinib tablets in four different strengths: 40mg, 80mg, 120mg, and 160mg. The approval covers additional indications, strengths, and new dosage forms beyond the previously approved selpercatinib capsules of 40mg and 80mg.
Selpercatinib is indicated for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have RET (搜索) fusion-positive genes. The drug requires genetic testing to confirm RET gene fusion before treatment initiation.
The committee's decision was supported by global bioequivalence study data (J2G-MC-JZJZ) for the 160mg tablet, food effect study results (J2G-MC-JZPA), and data from the ongoing Phase III LIBRETTO-531 study, which includes five Indian patients. The committee noted that selpercatinib, classified as an orphan drug, has already received approval in key markets including the United States, European Union, United Kingdom, Canada, and Australia.
Serplulimab Approval Expands PD-1 Inhibitor Options
In a separate decision at the May 13, 2025 SEC meeting, Intas Pharmaceuticals secured approval for serplulimab concentrate for solution for infusion (100mg/10ml vial). The company presented additional safety and efficacy data from global clinical studies while requesting a waiver for local clinical trials.
Serplulimab is a fully humanized IgG4 monoclonal antibody that targets the PD-1 (搜索) receptor, an immune checkpoint protein. The drug works by blocking PD-1, preventing cancer cells from suppressing the immune system's ability to attack tumors. Clinical trials have demonstrated promising anti-tumor activity and a manageable safety profile, particularly in lung cancer treatment.
The committee acknowledged that serplulimab has received approval from the European Medicines Agency (EMA) and falls under the orphan drug category, supporting its regulatory pathway in India.
Regulatory Requirements and Timeline
Both approvals come with stringent post-marketing surveillance requirements. Eli Lilly and Intas must submit their respective Phase IV clinical trial protocols to CDSCO (搜索) within three months of receiving marketing authorization. These trials will provide additional safety and efficacy data specific to the Indian patient population.
The Phase IV requirement reflects CDSCO (搜索)'s approach to balancing patient access to innovative cancer treatments with the need for population-specific safety data. This regulatory framework allows for faster access to globally proven therapies while ensuring appropriate oversight for Indian patients.
Market Impact and Patient Access
These approvals represent significant developments in India's cancer treatment landscape, particularly for patients with specific genetic markers. The availability of selpercatinib tablets in multiple strengths provides dosing flexibility for RET (搜索) fusion-positive NSCLC patients, while serplulimab adds another PD-1 (搜索) inhibitor option to the immunotherapy arsenal.
The orphan drug status of both medications acknowledges their importance in treating rare cancer subtypes, potentially facilitating future regulatory processes and patient access programs. The approvals also demonstrate India's regulatory alignment with international standards, as both drugs have established safety and efficacy profiles in major global markets.