Congratulate! Lilly's new breast cancer drug was approved by the US FDA today

Source: on September 29, 2017, on the eve of the long National Day holiday, Wuxi apptec received a good news from the US FDA Today, the FDA announced approval for Eli Lilly's verzenio (abemaciclib) to go public, in combination with fulvestrant, to treat adult patients with HR positive, HER2 negative advanced or metastatic breast cancer These patients had previously received endocrine therapy, but the disease is still progressing The FDA also approved verzenio to be used alone to treat the same group of patients who had received endocrine therapy and chemotherapy but had cancer metastasis The approval of this new drug will bring new hope to many patients Breast cancer is the most common cancer in the United States According to the National Cancer Institute (NCI), about 250000 women will be newly diagnosed with breast cancer this year, and about 40000 people will die of the disease Of these patients, 72% were HR positive and HER2 negative Bring new treatment plan for these patients, can bring great changes to the treatment pattern of breast cancer Verzenio, approved for marketing today, is such a potential new drug It is a CDK4 / 6 inhibitor In cells, CDK4 / 6 can promote tumor growth Therefore, by inhibiting CDK4 / 6, verzenio is expected to control the progress of breast cancer and improve the condition Previously, the new drug has been recognized as a breakthrough therapy by the U.S FDA ▲ the mechanism of action of abemaciclib (click the picture to view the large picture; source: Official Website of Lilly) in a clinical trial, the safety and efficacy of verzenio have been verified In this trial, 669 patients were recruited They all had HR positive and HER2 negative breast cancer After the treatment of endocrine therapy, the disease still developed The study found that among patients who received verzenio and fulvestrant, 16.4 months of PFS was higher than those who received placebo and fulvestrant (9.3 months) In addition, verzenio's safety and efficacy as a single therapy were tested in a clinical trial involving 132 patients After the treatment of endocrine therapy and chemotherapy, the patients with HR positive and HER2 negative still developed cancer After verzenio treatment, 19.7% of patients had complete or partial remission (CR) with a median objective remission time of 8.6 months The safety of verzenio is recognized both as a combination therapy and as a single therapy Therefore, the US FDA approved its listing today, bringing good news to patients as soon as possible It is worth mentioning that this is the third CDK4 / 6 inhibitor approved by the US FDA and the only CDK4 / 6 inhibitor approved as a single therapy Dr Richard pazdur pointed out that this treatment has brought new choices for patients (picture source: FDA), "verzenio has brought a new targeted treatment scheme for specific breast cancer patients These patients did not respond to the current treatment Unlike other new drugs in this category, this new drug can be used as a single therapy for patients who have received endocrine therapy and chemotherapy " Dr Richard pazdur, director of the FDA center of excellence in oncology and director of the office of Hematology and oncology products of the FDA Center for drug evaluation and research, commented We congratulate lilly on the approval of the new drugs and wish the new drugs to emerge in an endless stream and extend the life of patients.