NEW YORK (Reuters) - Michael Weitz was out of options. The Californian had endured chemotherapy, radiation and surgery but his lung cancer still spread to his bones and brain.
With time running out, the emergency room physician entered a Phase I study - the earliest stage of human testing for a new medicine - of crizotinib. The drug works for about 4 percent of advanced lung cancer patients with a mutated form of a protein called ALK.
"Once I knew that I had that mutation, I knew that I had an exciting new chance," said Weitz, now 55, who is cancer-free after three years of taking the drug now sold by Pfizer (NYSE: PFE - news) as Xalkori after an unusually swift development process.
It typically has taken a decade and $1 billion to bring a new treatment to market. But in the last two years a handful of cancer drugs - including Onyx Pharmaceutical Inc's Kyprolis for multiple myeloma, Roche's Zelboraf for melanoma, and Pfizer's Xalkori - were approved in about half that time because of improved genetic screening, more definitive Phase I trials and the dire need for new, effective treatments.
"We hope to be able to shave years off the time it takes to get final approval and save hundreds of millions of dollars per drug," said Robert Schneider, director of translational cancer research at New York University Cancer Institute. "We're going to see this as a sea change over the next five years."
Weitz's story is a dramatic example of how personalized medicine is advancing 10 years after researchers sequenced the human genome, enabling drugs to target specific genetic variations. The emerging trend is likely to bring more effective treatments to desperate patients faster, increase the number of annual drug approvals and cut research costs through earlier and more reliable data. It will also help drugmakers identify ineffective therapies sooner, although it may not necessarily lead to lower priced medicines.
There are some concerns about the faster approval process but most agree that the benefits of a potentially life-saving drug outweigh the risks. "The accelerated development of new drugs can be a double-edged sword," said Mace Rothenberg, head of oncology for Pfizer. "As you move more quickly some questions may be unanswered."
He said those answers can come from trials conducted after drugs are approved, and the Food and Drug Administration often requires post-marketing studies following expedited approvals
Historically, Phase I trials did little more than reveal the dose of an experimental drug that could safely be tolerated before larger studies determined clinically meaningful benefit. But advances in genetic screening and an improved understanding of the biology of cancer are enabling researchers to identify patients most likely to benefit from specific cancer treatments.
"You can see positive signals much more quickly, and clinically you can spare patients for whom the drug is not likely to work," said Dr. Michael Davies, assistant professor in the department of melanoma medical oncology at MD Anderson Cancer Center in Houston.
More here:
Insight - Cancer drugs proving worth earlier in testing
- Free Download MP3 Album Destroy Rebuild Until God Shows - DRUGS - February 17th, 2011 [February 17th, 2011]
- Free Download MP3 Album Designer Drugs - Hardcore/ Softcore - February 23rd, 2011 [February 23rd, 2011]
- Destroy Rebuild Until God Shows - "If You Think This Song Is About You..." [OFFICIAL VIDEO] - May 7th, 2011 [May 7th, 2011]
- Drugs Make You Ugly - May 7th, 2011 [May 7th, 2011]
- Bill Cosby Drugs - May 9th, 2011 [May 9th, 2011]
- Spiders On Drugs - May 10th, 2011 [May 10th, 2011]
- Ali-G Drugs - May 19th, 2011 [May 19th, 2011]
- 10 Celebrities Caught on Tape with Drugs - May 20th, 2011 [May 20th, 2011]
- Black Lips "Drugs" - May 20th, 2011 [May 20th, 2011]
- Hallucinate without the use of drugs, watch this - May 24th, 2011 [May 24th, 2011]
- Phil On Drugs..... - May 30th, 2011 [May 30th, 2011]
- Weezer - We Are All On Drugs - May 31st, 2011 [May 31st, 2011]
- Röyksopp - The Drug (Official Video) - June 1st, 2011 [June 1st, 2011]
- Anti-Drug Dog - June 1st, 2011 [June 1st, 2011]
- Drug problems - June 3rd, 2011 [June 3rd, 2011]
- Surfers: Iron's Drug Use Is A Let Down - June 9th, 2011 [June 9th, 2011]
- Betty Boop Cartoon Banned For Drug Use 1934 - June 13th, 2011 [June 13th, 2011]
- Ke$ha - Your Love Is My Drug - June 17th, 2011 [June 17th, 2011]
- Cokemobile: Video of insane armored drug truck used by Mexico cartels - June 18th, 2011 [June 18th, 2011]
- Love and Other Drugs Movie Trailer Official (HD) - June 25th, 2011 [June 25th, 2011]
- Ron Paul on legalizing drugs and gay marriage - SC Republican debate 5/5/2011 - June 30th, 2011 [June 30th, 2011]
- lil kim drugs - July 6th, 2011 [July 6th, 2011]
- Growing Number Of Vets Becoming Hooked On Drugs - July 13th, 2011 [July 13th, 2011]
- 'Bush, Reagan let drugs flow free to US from Nicaragua' - ex-dealer - July 14th, 2011 [July 14th, 2011]
- Drug taken by White before crash can impair vision - July 15th, 2011 [July 15th, 2011]
- Graveyard Dancing - DRUGS (Lyrics) - July 16th, 2011 [July 16th, 2011]
- War on Drugs: The Globalists Biggest Ponzi Scheme of All Time! - Alex Jones Tv Sunday Edition 2/2 - July 17th, 2011 [July 17th, 2011]
- The Shadow GOV deals the drugs - July 17th, 2011 [July 17th, 2011]
- Ohio Medicaid Russian Drug Smuggling Investigation - July 20th, 2011 [July 20th, 2011]
- Homemade drugs devastating Russian addicts - July 23rd, 2011 [July 23rd, 2011]
- Report: War On Drugs Has Failed - July 24th, 2011 [July 24th, 2011]
- Drug trafficking for 'justice' in Mexico - July 25th, 2011 [July 25th, 2011]
- Inside Story - Has the global war on drugs failed? - July 25th, 2011 [July 25th, 2011]
- War on Drugs: The Globalists Biggest Ponzi Scheme of All Time! - Alex Jones Sunday Edition 1/2 - July 26th, 2011 [July 26th, 2011]
- The Cost of the War on Drugs - July 27th, 2011 [July 27th, 2011]
- Joe Rogan - Marijuana the Gateway Drug - August 2nd, 2011 [August 2nd, 2011]
- Get Personal: Drugs - August 5th, 2011 [August 5th, 2011]
- Watching Daughter on Drugs - August 10th, 2011 [August 10th, 2011]
- Elite troops take sides in Mexican drugs wars - August 17th, 2011 [August 17th, 2011]
- Amy Winehouse on Drugs (Belgrade Live 2011) - August 18th, 2011 [August 18th, 2011]
- Fake War on Drugs: US Government is The Real Kingpin - Alex Jones Tv 1/2 - August 19th, 2011 [August 19th, 2011]
- Destroy Rebuild Until God Shows - Sex Life (Video) - August 19th, 2011 [August 19th, 2011]
- Falling In Reverse - "The Drug In Me Is You" - August 22nd, 2011 [August 22nd, 2011]
- Drug Tunnel - August 27th, 2011 [August 27th, 2011]
- Runescape on Drugs - September 1st, 2011 [September 1st, 2011]
- California On Drugs - September 4th, 2011 [September 4th, 2011]
- The War On Drugs- Slave Ambient ALBUM REVIEW - September 6th, 2011 [September 6th, 2011]
- Kids don't do drugs... - September 10th, 2011 [September 10th, 2011]
- Don't Do Drugs - September 11th, 2011 [September 11th, 2011]
- Drug Commercial (Jon Lajoie) - September 14th, 2011 [September 14th, 2011]
- Australian Story Love and Other Drugs P2 - September 24th, 2011 [September 24th, 2011]
- Losing the 'War on Drugs' - September 25th, 2011 [September 25th, 2011]
- Alternate Reality! Drugs! Science! - September 25th, 2011 [September 25th, 2011]
- The War on Drugs Has Failed - September 28th, 2011 [September 28th, 2011]
- End The Failed War On Drugs - Cenk on MSNBC - September 29th, 2011 [September 29th, 2011]
- Deus Ex: Human Revolution - Part 8: Drugs are bad m'kay - September 30th, 2011 [September 30th, 2011]
- Mike Posner - Drug Dealer Girl - October 3rd, 2011 [October 3rd, 2011]
- CIA Drug Ops Conspiracy-Unaired Documentary-Full Length - October 6th, 2011 [October 6th, 2011]
- People - October 9th, 2011 [October 9th, 2011]
- OSHO: About Drugs - October 10th, 2011 [October 10th, 2011]
- Drug Testing All College Students - October 10th, 2011 [October 10th, 2011]
- The Verve - The Drugs Don't Work - October 13th, 2011 [October 13th, 2011]
- Android dance, bugged robot on drugs ! - Video - October 17th, 2011 [October 17th, 2011]
- Iggy Azalea ft. YG 400 - DRUGS - Video - October 17th, 2011 [October 17th, 2011]
- A Nation On Drugs - Yemen - Video - October 18th, 2011 [October 18th, 2011]
- Eminem Drug Ballad - Video - October 20th, 2011 [October 20th, 2011]
- American Drug War: The Last White Hope: Pre Release Cut - Video - October 23rd, 2011 [October 23rd, 2011]
- The War On Drugs - "Baby Missiles" (Official Video) - Video - October 24th, 2011 [October 24th, 2011]
- Nine Inch Nails - The Perfect Drug (full) - 480p - Video - October 28th, 2011 [October 28th, 2011]
- DRUGS - Video - October 30th, 2011 [October 30th, 2011]
- Drugs, drugs, drugs! - Video - November 3rd, 2011 [November 3rd, 2011]
- World's Most Dangerous Drug - Video - November 5th, 2011 [November 5th, 2011]
- "The War on Drugs" explained by Graham Hancock - The Joe Rogan Experience - Video - November 6th, 2011 [November 6th, 2011]
- I Don't Like The Drugs (But The Drugs Like Me) - Video - November 7th, 2011 [November 7th, 2011]
- Hockey plane crash: Drugs and bad braking - Video - November 9th, 2011 [November 9th, 2011]
- Bill Hicks - Positive Drug Story - Video - November 10th, 2011 [November 10th, 2011]
- The Worst Anti-Drug Movie Ever - Video - November 12th, 2011 [November 12th, 2011]
- Huffington Post Honored for Drug Policy Coverage - Video - November 13th, 2011 [November 13th, 2011]
- NOFX - Drugs Are Good - Video - November 16th, 2011 [November 16th, 2011]
- DRUGS playing "Sex Life" in Detroit, MI - Video - November 17th, 2011 [November 17th, 2011]