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Published on : Oct 03, 2017

The U.S. Food and Drug Administration (FDA) has recently approved a new option for treating certain forms of advanced breast cancer patients who aren’t responding to the current drugs or therapies. The FDA approved the new targeted treatment Verzenio (abemaciclib) to treat cancer in adult patients with hormone receptor-positive HR-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, the type that has progressed after an endocrine therapy. The drug Verzenio (abemaciclib) is supplied by Eli Lilly and Company, a globally prominent pharmaceutical company based in the U.S.

Drug can be taken as Standalone Treatment in Metastasized Cancer

Verzenio can be given in combination with the endocrine therapy, called fulvestrant (Faslodex being the trade name), after the cancer cells have grown after the therapy. A unique advantage of the targeted treatment is that unlike other drug class it can be taken on its own by patients who have been earlier been treated with an endocrine therapy and chemotherapy but the cancer has metastasized.

Earlier, two other drugs in this class had been approved by the FDA: palbociclib (February 2015) and ribociclib (March 2017).

New Treatment to Contain Rising Incidence of Women with Advanced Breast Cancer

The approval considered as breakthrough offers new hope for a growing number of populations with cancer, with the National Cancer Institute estimating about 252,710 women to be diagnosed with breast cancer in 2017 alone. Of these, around three-fourth of the patients have tumors that are of type HR-positive and HER2-negative.

A new randomized trial consisting of 669 patients suffering with HR-positive, HER2-negative breast cancer to study the efficacy of Verzenio in combination with fulvestrant. In these patients, the cancer cells had been growing after having treated with endocrine therapy. In addition, they didn’t receive chemotherapy once the metastatic cancer had set in. The results were arrived on the basis of objective response rate, the parameter that measures the complete or partial shrinkage of tumor cells after Verzenio was administered.

The common side effects that the FDA listed include diarrhea, neutropenia, leukopenia, and anemia, with pregnant women prohibited to take the drug.