GlaxoSmithKline plc: GSK melanoma drug mixture wins accelerated U.S. authorization

Taken from:—GSK-melanoma-drug-combination-wins-accelerated-US-approval-17772297/

The green light for the combined use of Tafinlar, also known as dabrafenib, and Mekinist, or trametinib, from the Food and Drug Administration (FDA) is the first of its kind for a form of the disease with a specific genetic profile.

Both drugs are already approved for separate use but GSK believes they will have a longer-lasting effect if given together. News:
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Tafinlar, which is similar to Roche’s(»Roche Holding Ltd.) rival medicine Zelboraf, is designed to work in patients with a mutation of a gene known as BRAF. So-called BRAF inhibitors have been remarkably effective in shrinking melanoma tumours but most patients eventually develop resistance to the drugs.

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By combining Tafinlar with Mekinist, which works in a different way, the hope is that the cancer will be held at bay for longer.

The FDA approval, which was announced late on Wednesday, covers the treatment of melanoma that cannot be removed by surgery or which has spread to other organs.

Melanoma is diagnosed in nearly 160,000 people worldwide each year. It can spread quickly to internal organs and average survival is six to nine months.

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Vick: ‘I still feel like I can begin in this league’

Michael Vick continued to take the high road and gave Chip Kelly and his decision to start Nick Foles for the rest of the season his full endorsement.

"Me and Coach are always on the same page, from Day 1," Vick said. "We do a great job of communicating and it seems like we’re always on the same page. We’re always thinking pretty much the same and it makes it easy for all of us.”

Kelly announced earlier that Foles would be the start for the final five games of the season which begin Sunday when the Cardinals visit Lincoln Financial Field. The Eagles have won three straight with Foles at quarterback. As recently as two weeks ago, Vick seemed to have already read the writing on the wall and said that he didn’t want to become a distraction.

“It’s just in me,” Vick said Tuesday. “I’m not a selfish person at all. I don’t ever feel like the world revolves around me. I’ve been blessed. I’ve been blessed with the ability to play this game. I’m extremely talented. Like I said, I know I got a lot of football to play and that’s what keeps me going.”

Vick’s contract is up at the end of the season. The 33-year old said that he believes he can still start in the NFL. Still, he had to win the job this offseason and has now missed 16 games because of injury over the last four seasons.

“I feel like I can still start, yeah, in this league,” Vick said. “What do you think? No, honestly, what do you think?”

A reporter responded with a yes.

“Now you answered your own question,” Vick said. “I appreciate that.”

Vick opened the season with a victory as the Eagles beat the Redskins. But the Birds lost the next three with him at quarterback. For the most part, though, the team lost for myraid of reasons. He suffered a hamstring strain in the second quarter of the New York Giants game in Week 5 and Foles came in to guide the leading Eagles to a win.

Foles won the next week, but struggled against the Cowboys the following game and suffered a concussion. Vick returned against the Giants but re-injured his hamstring and sat out the next three games.

“Yeah, I think I’m 100 percent,” Vick said. “I think I’m finally back to 100 percent. It took a long time to get there. Hey, we just wanted to be cautious, wanted to do it the right way.”

Kelly said that Vick will backup Foles on Sunday. Vick has been the No. 2 quarterback before, most recently late last season when Andy Reid and the team wanted a longer look at Foles as a rookie and in 2010 when Kevin Kolb opened the season at the starter.

Kolb, of course, suffered a concussion in the opener. Vick replaced him, played well and kept the job for the rest of the season as the Eagles made the playoffs. But he and the Eagles regressed over the next two years. Many thought he wouldn’t be back for 2013, but Kelly offered Vick a one-year deal and a chance to compete for a starting job. He accepted.

“If I had to do it all over again I would do it,” Vick said. “Absolutely. I don’t regret anything. I had an injury and that happens in football. It’s nothing other than to continue to stay positive. I will never regret anything in my life. I never have, I never will. I’m still thankful I came back. I learned a lot, so much about football, so much about the game, so much about taking care of myself that it’s valuable information for me.”

Vick’s future remains cloudy, something he admitted weighed on his mind.

“It’s tough when your future’s uncertain, but you also have to look at the things that you did, the things that you was able to do well,” Vick said. “Hopefully, that’s enough to continue to show that I can continue to play. I feel good, I feel great, still feel like I have a lot of time to play this game. I’m still learning, so I’m excited about it. But I still have to focus on each and every day for the rest of this season, continue to try and help this team win games.”