CDSCO committee tells Roche to submit Phase III clinical trial data of blood cancer combo drug
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), recently recommended drugmaker, Roche to submit Phase III clinical trial data of Polatuzumab Vedotin, a blood cancer drug for which the firm had sought to waiver.
Roche presented its proposal for permission to import and marketing of the drug for the indication “Polatuzumab Vedotin in combination with bendamustine and rituximab is indicated for the treatment of previously treated adult patients with diffuse large B-Cell lymphoma (DLBCL) who are not candidate for hematopoietic stem cell transplant” with the waiver of Phase III and Phase IV clinical trial in the country.
In 2017, Roche had announced that the drug, in a mid-stage trial had shown a far higher rate of remission and helped patients with an advanced, aggressive blood cancer live significantly longer than the standard treatment alone.
The CDSCO committee recently noted that the drug has been approved by USFDA through accelerated approval process based on Phase II study on a limited number of patients for the indication in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies. As per USFDA approval, the firm is required to conduct two Phase III studies.
The CDSCO committee opined that although the proposed indication is a rare disease, considering the safety profile of the drug (GradeIII/IV toxicities of 84.6%), Phase III clinical trial data is required for further consideration. The committee also noted that efficacy data has been generated in the Phase II study with relatively weak comparator arm.
Therefore, the CDSCO committee recommended that the firm should submit Phase III clinical trial data of the drug.