Cancer Drugs Approved in 2012

          This is the first part of a two part article. The past decade has been very prolific as far as drug development and FDA approval for cancer treatments. Since we are starting the New Year I would like to give a recap of the drugs that were FDA approved in 2012.

          Two drugs were approved for colorectal cancer ZIV-aflibercept and regorafenib. Ziv-aflibercept (Zaltrap) is an antiangiogenic that prevents the growth of new blood vessels needed to feed the cancer, promoting growth; it is used in combination with FOLFIRI chemotherapy in the metastatic setting.

          Regorafenib is a tyrosine kinase inhibitor that interferes with normal cellular functions; it is an oral drug with hand foot syndrome as a major side effect.

          Pertuzmab (perjeta) was FDA approved for HER-2-NEU positive metastatic breast cancer giving an additional option first line combination with docetaxel and herceptin. Pertuxmab is a monoclonal antibody that binds to the extracellular domain of the HER-2-NEW receptor and in combination with herceptin maximizes the antibody dependent cellular toxicity. The heart function needs to be monitored every three months.

          An androgen receptor inhibitor was FDA approved in 2012 for prostate cancer called enzalutamide (Xtandi). It is an oral drug for metastatic castration resistant prostate cancer in patients who failed docetaxel, giving another option for metastatic cancer with considerably less side effects compared to chemotherapy.

          Myeloma is another difficult to treat disease that in the last few years has seen an explosion of new very effective drugs that have significantly changed the survival rate of these patients, by targeting newly discovered pathways. The latest drug FDA approved in 2012 for myeloma is Carfilzomib (kyprolis) a proteasome inhibitor which suppresses cell growth and enhances cell death. The drug is given intravenously over ten minutes two days a week for three weeks. Renal and cardiac function need to be monitored.

          CML is one of our major medical success stories regarding the development of highly successful treatments and in 2012 two additional drugs were FDA approved Bosutinib and omacetaxine succunate. Bosutinib is a tyrosine kinase inhibitor for the BCR-ABL kinase and is effective in CML resistant to Gleevec. It is an oral drug with side effects ranging from diarrhea, fluid retention and cytopenia it is metabolized by the liver and LFT’s need to be monitored.

          Omacetaxine (Synribo) is the second drug FDA approved in 2012 for refractory CML; it inhibits protein synthesis independent of direct BCR-ABL binding. Cytopenias represent the major side effect. There are currently five oral treatments extremely effective for CML and as of now the median survival for the disease is greater than thirty years without bone marrow transplant.

          Please look for part two of this article in next month’s edition.