European Approval for Glaxo's Tafinlar - Analyst Blog

By
A A A

GlaxoSmithKline ( GSK ) recently announced that its melanoma drug, Tafinlar, has been cleared by the European Commission (EC). Tafinlar is indicated as a monotherapy for treating adults suffering from unresectable or metastatic melanoma with a BRAF V600 mutation.

However, Tafinlar is not recommended for patients suffering from wild-type BRAF melanoma. Additionally, a presence of BRAF V600 mutation should be confirmed in the melanoma patients using a validated test before prescribing Tafinlar.

The approval came on the basis of encouraging data from several multi-center global trials including the phase III BREAK-3 study.


We remind investors that Tafinlar received approval as monotherapy in the U.S. in May 2013. The U.S. Food and Drug Administration (FDA) approved Tafinlar for BRAF V600E mutation-positive unresectable or metastatic melanoma patients. However, the FDA did not recommend the use of Tafinlar for patients suffering from wild-type BRAF melanoma. The FDA also cited several warnings and precautions related to the use of Tafinlar, which can lead to fatal side effects including increasing the risk of developing new primary cutaneous malignancies.

Glaxo intends to launch the drug in the U.S. shortly. Currently approved melanoma drugs include Zelboraf and Yervoy.

Glaxo carries a Zacks Rank #3 (Hold). We are pleased with Glaxo's label expansion efforts. Moreover, Glaxo boasts of a robust pipeline. A number of pipeline-related news is expected in the coming quarters. Given the declining sales from generic competition, we believe Glaxo's pipeline must deliver.

Companies that currently look well-positioned include Actelion Ltd. ( ALIOF ) and Gilead Sciences Inc. ( GILD ) with a Zacks Rank #1 (Strong Buy) and Jazz Pharmaceuticals ( JAZZ ) with a Zacks Rank #2 (Buy).



ACTELION LTD (ALIOF): Get Free Report

GILEAD SCIENCES (GILD): Free Stock Analysis Report

GLAXOSMITHKLINE (GSK): Free Stock Analysis Report

JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research



The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.




This article appears in: Investing , Business , Stocks

Referenced Stocks: ALIOF , EC , GILD , GSK , JAZZ

Zacks.com

Zacks.com

More from Zacks.com:

Related Videos

Stocks

Referenced

Most Active by Volume

105,668,238
  • $16.69 ▼ 1.48%
51,051,053
  • $8.29 ▲ 1.10%
50,476,494
  • $5.62 ▲ 0.18%
45,957,548
  • $18.20 ▼ 0.66%
45,849,373
  • $125.69 ▼ 0.25%
44,297,979
  • $17.25 ▼ 3.31%
43,161,110
  • $107.97 ▲ 0.25%
42,828,521
  • $29.90 ▼ 0.47%
As of 7/7/2015, 04:15 PM

Find a Credit Card

Select a credit card product by:
Select an offer:
Search
Data Provided by BankRate.com