Alkem Launches Cetuximab under the Brand Name Cetuxa in India

Mumbai: One of India's leading drug makers, Alkem Labs, has announced the launch of the world's first Cetuximab biosimilar in the country under the brand name Cetuxa. Cetuxa will be manufactured by Alkem’s fully-owned subsidiary Enzene Biosciences and is targeted to provide affordable treatment in cases of head and neck cancers.

Cetuxa has been approved by DCGI for the management of squamous cell cancers of the head and neck. It is available at Rs 9990, a price that is pegged to be 50% more cost-effective than other available brands. This is a huge breakthrough towards extending treatment accessibility in India, where head and neck cancers are the most prevalent and highly pervasive due to rampant tobacco consumption behaviours. Head and neck cancers constitute 30% of all cancer malignancies in India. (1)

Cetuxa is available as a 100mg (5mg/ml) single-dose vial intravenous injection and administered as a 400 mg/m2 initial dose over a 120-minute intravenous infusion followed by a 250 mg/m2 weekly infusion over 60 minutes.

The epidermal growth factor receptor (EGFR) is abnormally activated in epithelial cancers like head and neck cancer. Cetuximab – an IgG1 monoclonal antibody, is an EGFR inhibitor used to treat cancer by blocking the activity of EGFR and may keep cancer cells from growing.

Studies have substantiated that cetuximab improves the survival rate, overall response rate, disease-control rate, and time to treatment failure in metastatic squamous-cell carcinoma of the head and neck with radiotherapy and platinum-based chemotherapy (2, 3).

“Cetuxa is the world's first biosimilar of cetuximab; it has a proven record of better progression-free survival and overall survival compared to chemotherapy alone for managing head and neck cancer. Currently, less than 5% of patients can afford cetuximab, which makes it out of reach for patients from lower to middle socio-economic groups. With the launch of this biosimilar, we aim to ensure accessibility for the majority of the patients with affordable therapy cost and availability at most cancer management centers, said Mr. Sandeep Singh, MD, Alkem laboratories.

“Alkem’s cetuximab has proven biosimilarity with innovator cetuximab. Through Enzene, we endeavor towards building a world-class biotech company, and Alkem has also created exceptional capabilities in the clinical development of complex therapies, enabling us to facilitate positive influence on Indian healthcare”, added Mr. Sunil Pathak, Sr. vice president, Alkem laboratories

Speaking to Medical Dialogues team Dr. Himanshu Gadgil, Whole-time Director & Chief Scientific Officer, Enzene Biosciences Ltd added “As per Globocan statistics (4), India accounts for around 15% of the global Head and neck cancer disease burden. Due to the prevalence of tobacco usage, oral cavity cancers are much more common particularly in the lower income group. In fact, it is one of the leading causes of cancer-related death in India. With the Cetuxa launch, we are committed to an affordable relief to the Indian population suffering under the burden of these cancers”

References:

1) Chauhan R, Trivedi V, Rani R, Singh U. A Study of Head and Neck Cancer Patients with Reference to Tobacco Use, Gender, and Subsite Distribution. South Asian J Cancer. 2022 Feb 2;11(1):46-51. doi: 10.1055/s-0041-1740601. PMID: 35833037; PMCID: PMC9273320.

2) Vermorken, J. B., Mesia, R., Rivera, F., Remenar, E., Kawecki, A., Rottey, S., Erfan, J., Zabolotnyy, D., Kienzer, H. R., Cupissol, D., Peyrade, F., Benasso, M., Vynnychenko, I., De Raucourt, D., Bokemeyer, C., Schueler, A., Amellal, N., & Hitt, R. (2008). Platinum-based chemotherapy plus cetuximab in head and neck cancer. The New England journal of medicine, 359(11), 1116–1127. https://doi.org/10.1056/NEJMoa0802656

3) Bonner, J. A., Harari, P. M., Giralt, J., Azarnia, N., Shin, D. M., Cohen, R. B., Jones, C. U., Sur, R., Raben, D., Jassem, J., Ove, R., Kies, M. S., Baselga, J., Youssoufian, H., Amellal, N., Rowinsky, E. K., & Ang, K. K. (2006). Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. The New England journal of medicine, 354(6), 567–578. https://doi.org/10.1056/NEJMoa053422

4) Sung, H., Ferlay, J., Siegel, R. L., Laversanne, M., Soerjomataram, I., Jemal, A., & Bray, F. (2021). Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA: a cancer journal for clinicians, 71(3), 209–249. https://doi.org/10.3322/caac.21660