PADCEV™ (enfortumab vedotin) now available in India for locally advanced or metastatic urothelial cancer

Astellas Pharma India today announced that PADCEV™ (enfortumab vedotin) is now available for prescription in India as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (LA/mUC) who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor¹.

Enfortumab vedotin is a first-in-class antibody-drug conjugate that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer cells¹. Laboratory studies have shown that the anticancer activity occurs when it enters the cell and releases the cell-killing medicine that works to damage and kill the cell expressing nectin-4¹.

In India, urothelial carcinoma patients who have progressed beyond platinum-containing chemotherapy and immunotherapy currently lack a standard of care. Treatment options for this population are limited and this launch will address a significant unmet need.

The launch of PADCEV™ reinforces Astellas’ commitment to expanding its oncology portfolio in India. Following the introduction of Xospata™ (Gilteritinib) last April for relapsed or refractory FLT3+ acute myeloid leukemia (AML), PADCEV™ marks another step in the company’s mission to deliver innovative cancer therapies to Indian patients.

“This launch marks a significant milestone for India. The approval of enfortumab vedotin provides a new treatment option for patients living with advanced urothelial cancer who have had limited treatment options thus far. It also further demonstrates our continued commitment to bringing global innovations to India and making a real impact on patient’s lives,” said Sampada Gosavi, General Manager and Managing Director, Astellas India.

About Urothelial Cancer

Urothelial cancer is the most common type of bladder cancer (90 per cent of cases) and can also be found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra¹.

About the EV-301 Trial

The EV-301 trial (NCT03474107) was a global, multicentre, open-label, randomised phase 3 trial designed to evaluate enfortumab vedotin versus physician’s choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in 608 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1/L1 inhibitor and platinum-containing therapies². The primary endpoint was overall survival and secondary endpoints included progression-free survival, overall response rate, duration of response and disease control rate, as well as of safety/tolerability and quality-of-life parameters. Results were published in the New England Journal of Medicine.

About PADCEV™ (enfortumab vedotin)

PADCEV™ is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer^1,3. Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalisation and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis)¹.

References

1. PADCEV India Prescribing Information.
2. American Society of Clinical Oncology. Bladder cancer: introduction (5-2019). https://www.cancer.net/cancer-types/bladder-cancer/introduction. Accessed March 2022.
3. Powles T, Rosenberg JE, Sonpavde GP, et al. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021; 10.1056/NEJMoa2035807.
4. Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13.

(No edits done by the Express Pharma team)