AstraZeneca Olaparib gets CDSCO Panel okay for BRCA mutated HER2 negative breast cancer
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New Delhi: Based on the scientific data provided by the drug maker AstraZeneca, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has given its nod for the additional indication of the anticancer Drug Olaparib film coated tablet 100/150 mg for breast cancer with adult patients with BRCA-mutated HaeR2- negative.
This came after the firm-presented interim report of the ongoing Phase IV clinical trial of Olaparib Film Coated Tablet 100/150 mg as per the condition of the permission (IMP-ND-189/2018) granted to the firm.
In addition, the expert panel opined that the firm should submit CSR of the ongoing Phase IV clinical trial in an already approved indication (vide permission no. IMP-ND-189/2018 dated 13.08.2018) for taking further action in the matter.
In continuation with the above, at the recent SEC meeting for Oncology and Hematology held on 13.07.2022, the expert panel reviewed the interim report ongoing Phase IV clinical trial of Olaparib Film Coated Tablet 100/150 mg.
Furthermore, the committee noted the interim results of the ongoing Phase IV clinical trial of Olaparib Film Coated Tablet 100/150 mg.
After detailed deliberation, the committee recommended the grant of permission for the additional indication "As monotherapy for the adjuvant treatment of adult patients with BRCA-mutated HER2- negative high-risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy" for Olaparib film-coated tablet 100/150 mg.
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