The Subject Expert Committee (SEC), which advises the Central drug regulator, has recommended grant of permission to Glenmark Pharmaceuticals to import and market cancer drug tislelizumab injection in the country with waiver of local clinical trial, subject to conditions.
The drug is one of the two oncology medicines for which the company has in May, 2024, announced an exclusive marketing and distribution agreement between its subsidiary Glenmark Specialty SA, and global oncology firm BeiGene. The other oncology drug under the agreement is Zanubrutinib, said the company during the time.
The SEC for Oncology, in a meeting in the middle of this month, considered Glenmark's request for approval of tislelizumab injection 100 mg (10ml) per vial. The company has submitted safety and efficacy data of 28 Indian patients with non-small cell lung cancer (NSCLC) and head neck squamous cell cancer (HNSCC) who participated in the Global Clinical Trial (GCT), in line with an earlier recommendation of the Committee.
The committee noted that the proposed indications come under the category of orphan drug and there is an unmet medical need in the country.
"After detailed deliberation, the committee recommended for the grant of permission to import and market the drug with waiver of local clinical trial with condition to conduct phase IV clinical trial in India for both the proposed indications," it said.
Accordingly, the company shall submit phase IV clinical trial protocol to Central Drugs Standard Control Organisation (CDSCO) within three months of grant of marketing authorisation.
In an earlier meeting in November, 2024, the Committee while considering the request, said that the firm presented the safety and efficacy data from various global clinical studies in the proposed indications. The meta data of safety and efficacy in comparison with other approved monoclonal antibodies was also deliberated.
The committee also noted that the drug is approved in USA, Europe, United Kingdom, Australia, China and other countries.
However, during the meeting, the Committee noted that safety and efficacy data is not available in Indian patients. The Committee recommended the firm to submit the safety and efficacy data of Indian patients. Following this, the company submitted the data and the same was considered while recommending grant of permission by the SEC in the latest meeting.
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