- In June 2024, The U.S. Food and Drug Administration (FDA) granted accelerated approval to adagrasib in combination with cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC). This approval was based on the KRYSTAL-1 study, which showed an overall response rate of 34% in previously treated patients, highlighting a new therapeutic option for a specific subset of CRC patients
- In June, China's National Medical Products Administration (NMPA) approved a cetuximab beta injection in combination with FOLFIRI (leucovorin, fluorouracil, and irinotecan) as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC). This approval is a significant milestone, as it introduces a new biosimilar option into a major market, potentially increasing accessibility and affordability of cetuximab-based therapies for a large patient population
- In November 2024, Cetuximab (Erbitux) received public funding in New Zealand for specific bowel cancer patients. This targeted treatment is now available for patients with metastatic colorectal cancer on the left side of the colon, with testing confirming the disease is RAS and BRAF wild-type. This development is a significant step towards increasing patient access to this established therapy
- In December 2024, A clinical trial demonstrated that cetuximab outperformed durvalumab when combined with radiation therapy for people with locally advanced head and neck cancer who are unable to receive cisplatin. This finding provides valuable guidance for treatment decisions in this patient population, showing better outcomes with cetuximab in terms of progression-free survival.
- In May 2023, Enzene Biosciences Limited, an Indian contract development and manufacturing organization, launched a biosimilar version of Cetuximab, aiming to enhance cancer treatment accessibility. This marked the first approved biosimilar for cetuximab in some markets, offering a more affordable treatment option. Simultaneously, Lupin Limited partnered with Enzene Biosciences Limited to further facilitate the launch of this biosimilar for head and neck cancer in India, highlighting the growing trend of biosimilar development and market expansion
