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.
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.
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.
