BDR Pharmaceutical Gets CDSCO Panel Nod To Manufacture Market anticancer drug Tucatinib Tablets
New Delhi: Agreeing for Phase III clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to BDR Pharmaceutical to manufacture and market the anticancer drug Tucatinib Tablets 50 mg/150mg with the condition that the drug should be sold by retail under the prescription of an oncologist only.
In addition, the expert panel opined that the firm should conduct a structured Phase IV clinical trial in at least 200 patients for which the protocol should be submitted within 3 months of approval of the drug for review by the committee.
This came after the firm presented the proposal for grant of permission for manufacturing and marketing of the drug Tucatinib Tablets 50 mg/150mg along with justification for the waiver of the Phase III clinical trial before the committee.
Tucatinib is a cancer drug that's used to treat certain types of breast and colorectal cancer. It's a small molecule that binds to the HER2 protein on cancer cells, preventing them from growing and dividing.
Tucatinib inhibits the tyrosine kinase enzyme of the HER-2 gene. Mutations of tyrosine kinase in the HER-2 gene lead to cascade effects of increased cell signaling and proliferation, resulting in malignancy.
Mutations in the HER-2 gene are observed in some types of breast carcinoma. Tucatinib inhibits the tyrosine kinase enzyme of the HER-2 gene. Mutations of tyrosine kinase in the HER-2 gene lead to cascade effects of increased cell signaling and proliferation, resulting in malignancy. Results of in vitro studies show that tucatinib inhibits the phosphorylation of both HER-2 and HER-3, leading to downstream changes in MAPK and AKT signaling and cell proliferation. Anti-tumor activity occurred in the cells that expressed HER-2. In vivo, tucatinib has been shown to inhibit HER-2-expressing tumors, likely by the same mechanism.
At the recent SEC meeting for Oncology, BDR Pharmaceutical presented data on the prevalence of the disease HER2-positive breast cancer.
The committee considered the subject drug as defined in NDCT Rules 2019 as an orphan drug. The committee noted that it is an orphan drug approved in other countries like the USA, EU, etc. The committee agreed for a Phase III CT waiver.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the drug Tucatinib Tablets 50 mg/150 mg for the applied indication, subject to the following conditions:
1. The drug should be sold by retail under prescription of Oncologist only.2. The firm should conduct structured Phase IV clinical trial in atleast 200 patients for which the protocol should be submitted within 3 months of approval of the drug for review by the committee.
Also Read: Folic Acid Dosage Mislabeling: CDSCO Panel Proposes Urgent Correction in Drug Rules
