At the SEC meeting for Oncology & Haematology held on 11th of May 2023, the expert panel reviewed the proposal for approval of additional indications (Renal Cell Carcinoma and Triple Negative Breast Cancer) of Pembrolizumab Injection (Keytruda) 100mg/4ml (25mg/ml solution in a single vial) presented by MSD Pharmaceuticals.
The expert panel noted that the firm presented the clinical data of ongoing Phase IV studies in India (KEYNOTE-593) and data from ongoing global clinical trial studies for proposed indications (KEYNOTE-426, KEYNOTE-564, KEYNOTE-355, and KEYNOTE-522). The proposed indications are approved in key countries like USA, UK, and Japan.
After detailed deliberation and based on the global clinical trial data, the committee recommended the grant of permission for Pembrolizumab injection (25mg/ml) for the following additional indications with a local clinical trial waiver:
1. Pembrolizumab, in combination with Axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults
2. Pembrolizumab, as monotherapy, is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.
3. Pembrolizumab, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumors express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease.
4. Pembrolizumab, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence.