Eli Lilly and Company received an FDA approval for its Cyramza on 13 May 2019. The product is approved for the second line treatment of patients having an elevated level of alpha-fetoprotein levels and advanced hepatocellular carcinoma. The approval was granted based on the results of phase III clinical trials performed on patients selected through biomarker and having alpha-fetoprotein level more than or equal to 400ng/mL. The focus group also included patients who have been treated with Nexavar (a product of Bayer which contains sorafenib) earlier. In addition to the approval, the FDA removed boxed warning related to impaired wound healing, gastrointestinal perforation, and hemorrhage.
Andrew X. Zhu, MD from Harvard Medical School and Massachusetts General Hospital Cancer Center admitted that the new drug approval is crucial for the treatment of patients with elevated levels of alpha-fetoprotein concentration since earlier, no specific treatment was available. On the other hand, Eli Lilly Oncology’s president, Anne White said, “the company is focused on offering cancer medications to help patients improve their battle against cancer. Eli Lilly is putting efforts to develop precision medicine-based therapies to make its patients battle stronger.”
As mentioned by the president, the company has 4 molecules under phase III trial, 8 molecules in phase II trial and 13 molecules in phase I trial. Eli Lilly is involved in the development of drugs for various types of cancer which include, sarcoma, lung cancer, breast cancer, gastrointestinal cancer, gynecological cancer, genitourinary cancer, and early development. The area of research mainly includes cancer cell signaling, immune-oncology, and cancer angiogenesis and tumor microenvironment. With a wide area of research and many promising molecules in the pipeline, the company will be playing a significant role in the oncology market in the near future. However, we have to wait to know when and how it launches its breakthrough technologies.