GlaxoSmithKline (GSK) announced that the U.S. Food and Drug Administration (:FDA) has granted priority review designation to the supplemental New Drug Applications (sNDAs) for the Tafinlar (dabrafenib)-Mekinist (trametinib) combination. The company is looking to get Tafinlar in combination with Mekinist approved for the BRAF V600 E or K mutation-positive unresectable or metastatic melanoma indication. The FDA is expected to render a decision on the Mekinist supplement by Jan 8, 2014 and the Tafinlar supplement by Jan 9, 2014.
The regulatory applications contain data from a phase I/II study evaluating Tafinlar in combination with Mekinist versus Tafinlar alone in patients suffering from BRAF V600E or K mutation positive metastatic melanoma. The company is also looking to get the combination therapy approved in Europe for use in adults with BRAF V600 mutation-positive metastatic melanoma and has submitted a marketing application for the same in Feb 2013.
We remind investors that both the melanoma drugs, Tafinlar and Mekinist, received approval as monotherapy in the U.S. in May 2013. Other approved melanoma drugs include Roche’s (RHHBY) Zelboraf.
Meanwhile, Glaxo was also in the news recently when the company and Genmab announced that their oncology drug, Arzerra has received Breakthrough Therapy designation from the FDA. The companies are looking to get the candidate approved in combination with Leukeran (chlorambucil) in treatment-naive chronic lymphocytic leukaemia (:CLL) patients, who have not been previously treated for the disease and are inappropriate for fludarabine-based therapy.
The FDA granted Breakthrough Therapy designation based on encouraging results from a phase III trial (n > 400) which evaluated the use of Arzerra in treat-naive CLL patients.
We note Arzerra is already approved for the treatment of patients with CLL refractory to Sanofi’s (SNY) Campath (alemtuzumab) and Fludara (fludarabine).
Glaxo, a large cap pharma company, carries a Zacks Rank #3 (Hold). We are pleased with Glaxo’s pipeline development efforts. A number of pipeline-related news is expected in the coming quarters. Given the declining sales due to generic competition, we believe Glaxo’s pipeline must deliver.
Roche and Novo Nordisk (NVO) are favorably placed in the large cap pharma space with a Zacks Rank #2 (Buy).