Roche Gets CDSCO Panel Nod To study Anticancer FDC Pertuzumab, Trastuzumab
New Delhi: Based on the justification provided by the drug major Roche, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to conduct the Phase IIIb clinical trial of the anticancer fixed-dose combination (FDC) drug Pertuzumab plus Trastuzumab.
This came after the drug major Roche presented the proposal for the grant of permission to conduct Phase IIIb clinical trial vide protocol no. MO43110, version 1.0 dated 02-Feb-2022 before the committee.
Pertuzumab is an antineoplastic agent used in the treatment of HER2-positive metastatic breast cancer in combination with other antineoplastic agents.
Pertuzumab is indicated for intravenous administration in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
It is also indicated in combination with trastuzumab and other chemotherapies for the neoadjuvant treatment of HER2-positive locally advanced, inflammatory, or early-stage breast cancer as part of a complete treatment regimen and as adjuvant treatment in patients with HER2-positive early-stage breast cancer at high risk of recurrence.
Pertuzumab is also indicated for subcutaneous injection in combination with trastuzumab and hyaluronidase in the treatment of HER2-positive breast cancers in adults.
Pertuzumab may mostly act to inhibit the classical signaling pathways stimulated by active HER2, including receptor dimerization, receptor phosphorylation, and the activation of signaling proteins downstream from HER receptors, including Erk and Akt.
Trastuzumab is a monoclonal anti-human epidermal growth factor receptor 2 protein antibody used to treat HER2-positive breast, gastroesophageal, and gastric cancers.
Trastuzumab is indicated as a first-line treatment, in combination with paclitaxel, for metastatic HER2-overexpressing breast cancer, and as monotherapy in patients who have previously received one or more chemotherapy regimens in the metastatic setting.
Trastuzumab is also indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
Trastuzumab binds to an extracellular domain of this receptor and inhibits HER2 homodimerization, thereby preventing HER2-mediated signaling.
At the earlier SEC meeting, responding to Roche's proposal for a Phase IIIB clinical study of Pertuzumab and Trastuzumab, the expert panel advised the firm to submit all previous approval of the proposed combination product to CDSCO.
Now in continuation, at the recent SEC meeting for Oncology and Hematology held on 30th May 2023, the expert panel reviewed the proposal presented by drug major Roche for the grant of permission to conduct Phase IIIb clinical trial vide protocol no. MO43110, version 1.0 dated 02-Feb-2022 before the committee.
After detailed deliberation, the committee recommended the grant of permission to conduct the proposed Phase IIIb clinical trial based on justifications as presented by the firm.
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