AstraZeneca Pharma India gets CDSCO Panel nod for Anti-cancer Drug Osimertinib Tablets 40 mg and 80 mg
New Delhi: With the condition of conducting a Phase IV clinical trial study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to AstraZeneca Pharma India to import and market Osimertinib tablets 40mg and 80 mg for the proposed additional indication.
This came after AstraZeneca Pharma India presented the proposal for a grant of permission to import and market Osimertinib tablets 40mg and 80 mg (additional indication) along with global clinical trial data before the committee.
Osimertinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors.
Osimertinib is used to help prevent a certain type of non-small-cell lung cancer (NSCLC) from returning after the tumor(s) has been removed by surgery in adults. Osimertinib is also used to treat a certain type of NSCLC that has spread to nearby tissues and cannot be removed by surgery in people who have responded to chemotherapy and radiation treatments. It is also used alone and in combination with other chemotherapy medications as a first treatment for a certain type of NSCLC that has spread to nearby tissues or to other parts of the body in adults.
Osimertinib is also used to treat certain types of NSCLC that have spread to other parts of the body in people who could not be treated successfully with other similar chemotherapy medications.
The firm has informed that the proposed drug, Osimertinib tablets 40mg and 80 mg already approved in the country on 29.05.2017, 03.08.2018 and 09.03.2021 for other indications.
The firm has also informed that Osimertinib tablets 40mg and 80 mg for the proposed indication are already approved in the United States, the European Union (27 Member States), Switzerland, Australia, South Korea and China.
At the recent SEC meeting for oncology, the expert panel reviewed the proposal presented for a grant of permission to import and market Osimertinib tablets 40mg and 80 mg (additional indication) along with global clinical trial data.
After detailed deliberation, the committee recommended the grant of permission to Osimertinib tablets 40mg and 80 mg for the proposed additional indication, subject to the condition that the firm should conduct a Phase IV clinical trial study.
Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 03 months from the date of approval of the drug product for further review by the committee.
Also Read: Novartis Healthcare Gets CDSCO Panel Nod To study Anti-cancer Drug Asciminib
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