CDSCO Approves Astellas' PADCEV-Pembrolizumab Combo for Advanced Bladder Cancer

According to the company, the approval marks the first approved combination therapy in India offering an alternative to platinum-containing chemotherapy, which has long remained the standard first-line treatment for advanced urothelial cancer.

The approval was supported by findings from the Phase 3 EV-302 clinical trial, which evaluated the efficacy and safety of enfortumab vedotin in combination with pembrolizumab in patients with previously untreated locally advanced or metastatic urothelial cancer.

Data from the study showed that the combination therapy achieved a median overall survival of 31.5 months compared to 16.1 months with platinum-containing chemotherapy. The trial demonstrated a 53 per cent reduction in the risk of death, with a hazard ratio of 0.47.

The combination therapy also showed improved progression-free survival, with patients receiving the regimen recording a median progression-free survival of 12.5 months compared to 6.3 months in the chemotherapy arm. The study reported a 55 per cent reduction in the risk of disease progression or death.

The EV-302 trial enrolled 886 patients with previously untreated locally advanced or metastatic urothelial cancer who were eligible for cisplatin- or carboplatin-containing chemotherapy irrespective of PD-L1 status. Patients were randomised to receive either enfortumab vedotin plus pembrolizumab or platinum-based chemotherapy.

According to the company, the safety profile observed in EV-302 was consistent with previous studies involving the combination. The most common Grade 3 or higher adverse events included maculo-papular rash, hyperglycaemia, neutropenia, peripheral sensory neuropathy, diarrhoea and anaemia. No new safety concerns were identified during the trial.

PADCEV is a first-in-class antibody-drug conjugate targeting Nectin-4, a protein highly expressed in bladder cancer cells. The therapy delivers monomethyl auristatin E (MMAE), an anti-tumour agent designed to inhibit cancer cell growth and induce apoptosis.

Apart from India, the enfortumab vedotin-pembrolizumab combination has already received approvals in the United States, Europe, Canada, Australia and several Asian countries.

PADCEV monotherapy is also indicated for adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.

Astellas Pharma focuses on therapies across oncology, ophthalmology, urology, immunology and women’s health, with ongoing research programmes targeting diseases with high unmet medical needs.