Regulatory Approval not required for retrospective analysis of Inotuzumab ozogamicin: CDSCO panel Tells Pfizer
New Delhi: In response to the drug major Pfizer's proposal to conduct the retrospective and non-interventional study of the anticancer drug Inotuzumab Ozagamicin, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that this study does not require regulatory approval as the study is for retrospective evaluation of data from medical records of patients who have already been treated with the drug and recommended.
However, the committee also opined that the firm should follow the other applicable guidelines.
This came after the firm presented its protocol for the conduct of a retrospective, non-interventional study titled, “A retrospective analysis of Inotuzumab ozogamicin (Inonza) usage in adult patients with relapsed/refractory (R/R) B-cell Acute Lymphoblastic Leukaemia (ALL)” as per protocol number B1931043, version 1.0 dated 14 Nov. 2022.
Inotuzumab ozogamicin, sold under the brand name Besponsa, is an antibody-drug conjugate medication used to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Inotuzumab is a humanized anti-CD22 monoclonal antibody bound to a toxic natural product calicheamicin. Inotuzumab is internalized by endocytosis into the cytoplasm. Calicheamicin moves to the nucleus, binds to a minor DNA groove, and causes a break in the double-stranded DNA and arrest cycle in the G2/M phase.
At the recent SEC meeting for Oncology and Hematology held on 27th April 2023, the subject expert panel reviewed the protocol for conducting the retrospective, non-interventional study titled “A retrospective analysis of Inotuzumab ozogamicin (Inonza) usage in adult patients with relapsed/refractory (R/R) B-cell Acute Lymphoblastic Leukaemia (ALL)” as per protocol number B1931043, version 1.0 dated 14 Nov. 2022.
After detailed deliberation, the committee noted that the study is for retrospective evaluation of data from medical records of patients who have already been treated with the drug.
Additionally, the expert panel recommended that this study does not require regulatory approval. Furthermore, the expert panel directed that other applicable guidelines should be followed.
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