Cm-Produced Cancer Treatment Receives FDA Approval
Eli Lilly and Company’s continuous manufacturing (CM) kits have proven to be an important manufacturing platform for the company’s oral solid dosage products (OSD). “CM is very important to Lilly as one of our proven manufacturing platforms for commercial dry products,” says David Sternasty. “We’ve seen a number of benefits and advantages, and our development pipeline is directed towards this technology where applicable.”
The company’s most recent success with CM technology was acknowledged on 28 September 2017, when the US Food and Drug Administration (FDA) approved Lilly’s Verzenio (abemaciclib) for the treatment of advanced breast cancer. Verzenio is Lilly’s first approved oral dosage medicine made using the CM process, and only the third CM-made medicine approved by the FDA. Verzenio’s approval represents a significant milestone in Lilly’s efforts to advance CM science and engineering. The company credits strategic partnerships among its development, manufacturing, quality, and regulatory teams as key to the successful implementation of CM and approval of Verzenio.
Lilly noted during project development that CM had the potential to shorten the drug development cycle. “Verzenio is our first medicine to be manufactured using CM and the other products are still in the pipeline, so it is still early to draw conclusions,” says Sternasty. “However, by doing our development at the same scale as manufacturing, and by replacing large-scale tumble blending with in-line mixing, many lengthy late-phase batch development activities are eliminated, which can make overall development timelines shorter.”
Verzenio, which works by blocking molecules (cyclin-dependent kinases 4 and 6) involved in the growth of cancer cells, was approved in combination with fulvestrant for the treatment of women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer with disease progression following endocrine therapy. It is also approved as monotherapy for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
Breast cancer is the most common form of cancer for women, according to the American Cancer Society, comprising as many as 25% of all new cancer diagnoses in women worldwide. In the United States, the National Cancer Institute at the National Institutes of Health estimates that nearly 253,000 women will be diagnosed with breast cancer this year, and 40,610 will die of the disease. Approximately 72% of patients with breast cancer have tumors that are HR+ and HER2-.
As with any of its manufacturing platforms, Lilly’s plans for further replication or expansion of CM will be driven by business needs and other aspects considered part of its strategic planning process.
The latest ICH guideline, ICH Q12,International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Q12. Final Version.” 20 November 2019....
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