FDA Okays First Two-Drug Treatment For Melanoma

With its new melanoma treatment deemed ready for market, GlaxoSmithKline (NYSE: GSK  ) made advancements into a promising area of cancer research. It involves the use of a combination of agents that target different areas affecting the growth of cancer cells.

The first FDA approval for a two-drug treatment for melanoma, a deadly form of skin cancer, involves the combined treatment of Tafinlar (dabrafenib) and Mekinist (trametinib). Each drug, along with an approved diagnostic test, received FDA approval in 2013 individually to treat a late-stage form of melanoma that has spread or is considered inoperable.

The therapy applies to patients that have two mutations of the disease. The approved companion drug test confirms if melanoma patients have the BRAF V600E or V600K mutation. It is estimated that about half of patients newly diagnosed with melanoma carry one of the mutations. Tafinlar targets primarily BRAF V600E, while Mekinist treats both V600E and V600K.

The phase II trial presented data that favored the combined treatment over the use of Tafinlar by itself. The combined treatment was found to be more effective in a greater number of patients and had a longer duration of response, or the length of time that cancer cells stabilize before additional treatment is required. There are several adverse events associated with the use of both treatments, including an increase in other less harmful forms of skin cancers, hemorrhaging, blood clots, and heart problems .

Oncology has higher sales despite drop in pharma segment
This latest drug approval adds another product to GlaxoSmithKline's important oncology pipeline. The oncology segment is a key growth area, along with the respiratory and vaccine business segments. New products helped the oncology segment's sales rise 14%, which excluded contributions from recently launched products.

The company's net earnings for the third quarter ended Sept. 30, 2013 were $1.57 billion. U.S. pharmaceuticals and vaccines segments were negatively affected by 3% due to a decrease in inventories maintained by wholesalers and retailers. However, GSK reaffirmed its guidance for fiscal 2013 EPS growth of 3% to 4% and sales growth of about 1 %.

New treatment can challenge other melanoma therapies
The two-drug combo may prove to be a welcomed option for patients using standard chemotherapy. Treatments, such as Novartis' (NYSE: NVS  ) melanoma drug Proleukin (aldesleukin), which is part of the company's mature products line. This product line has been decreasing in importance in the last three years and is also subject to competition from the generics. Novartis' overall oncology pipeline is estimated to deliver more than $1 billion in sales by 2017.

Like GlaxoSmithKline, Novartis is moving toward a new phase in cancer treatments that are personalized to each individual patient. A new therapy on the drawing board involves the use of CART cells, which are patient immune cells that are reengineered to fight cancer and injected back into the patient. With its broad oncology pipeline, the company is also looking into combining products that target mutations .

Another advanced stage melanoma therapy, manufactured by Bayer (NASDAQOTH: BAYRY  ) , is DTIC-Dome (dacarbazine). Like Proleukin, the drug is a traditional form of chemotherapy with multiple side effects. The company has supplied the drug since its approval in 1975 even though there are generic versions of it. The drug is not a major contributor within Bayer's broad product line and its use may continue to decline as new cancer therapies enter the market. The company's latest oncology drugs include Stivarga, for gastrointestinal cancer, and Xofigo, for prostate cancer. Both drugs contributed to the 8.6% increase in sales for the pharmaceuticals segment .

My Foolish conclusion
The approval of this new combination therapy adds to GSK's drug pipeline a cutting edge therapy for treating late stage melanoma that is inoperable or has spread to other areas of the body. This targeted therapy has the potential to become popular with doctors seeking a new melanoma treatment option with fewer side effects than standard chemotherapy.

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