Pfizer has received a nod from the Central Drugs Standard Control Organization (CDSCO) panel to conduct a clinical trial of its anticancer drug, Disitamab vedotin, in India. The panel’s approval will enable the company to proceed with the study, which is expected to begin soon.
Disitamab vedotin is a cancer treatment that targets the HER2 protein, which is overexpressed in many aggressive forms of breast, gastric, and other types of cancer. The drug works by binding to the HER2 protein, which then triggers the destruction of the cancer cells.
The clinical trial will be conducted by Pfizer’s Indian subsidiary, Pfizer India, in collaboration with leading cancer hospitals and research institutions in the country. The trial will involve approximately 200 patients with advanced breast, stomach, and throat cancers, the company said.
CDSCO is the most important pharmaceutical regulator in India, responsible for ensuring the quality, safety, and efficacy of drugs available in the country.approval from the panel is an essential step in the regulatory process, allowing Pfizer to conduct clinical trials in India, which is seen as a cost-effective and efficient way to develop and test new drugs.
India is a significant market for pharmaceuticals, with a large patient base and a growing need for new and innovative treatments. Pfizer’s Disitamab vedotin has the potential to address this need, and the company is well-positioned to be a significant player in the Indian market.
In approving Pfizer’s proposal, the CDSCO panel cited the company’s submission of solid data on the drug’s efficacy and safety in preclinical studies, as well as its proposed plan for the conduct of the clinical trial, which includes measures to ensure patient safety and data integrity.
The success of the clinical trial will depend on a number of factors, including the effectiveness of Disitamab vedotin in treating various types of cancer, the potential for side effects, and the level of patient acceptance. If the drug is found to be effective and safe, it could provide a new treatment option for patients with advanced breast, stomach, and throat cancers in India and potentially other countries.