Navigation Links
Pharmacyclics Receives Non-Approvable Letter from the FDA for Xcytrin for the Treatment of Lung Cancer Brain Metastases
Date:12/21/2007

SUNNYVALE, Calif., Dec. 21 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) for the company's new drug application (NDA) for Xcytrin(R) (motexafin gadolinium) Injection for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases. The NDA for use of Xcytrin in combination with whole brain radiation therapy (WBRT) was filed with the FDA in April 2007.

According to the National Cancer Institute, over 200,000 patients will be diagnosed with lung cancer this year in the U.S. Lung cancer is the most common cause of brain metastases, which are estimated to occur in up to 50% of lung cancer patients.

Pharmacyclics recently completed patient enrollment in three Phase 2 trials evaluating Xcytrin in patients with advanced relapsed NSCLC. These multi-center trials will evaluate Xcytrin as a single agent, in combination with Taxotere(R) (docetaxel), and in combination with Alimta(R) (pemetrexed). Data from these trials is expected in the first half of 2008.

"We are disappointed that brain metastases patients with limited options and serious neurologic problems will not have access to Xcytrin, which we believe has shown important clinical activity in this indication," said Richard A. Miller, M.D., president and chief executive officer of Pharmacyclics. "We continue to believe that Xcytrin is a novel active cancer drug and we will seek a corporate partner to help support future development. In the meantime, we are also advancing our expanding and versatile pipeline of product candidates."

Xcytrin's novel mechanism enables it to selectively concentrate in tumors and induce apoptos
'/>"/>

SOURCE Pharmacyclics, Inc.
Copyright©2007 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine news :

1. Lake Elsinore Family Caregiver Receives Free Power Wheelchair From The SCOOTER Store
2. DaVita Receives Civil Complaint
3. Ranbaxy Receives Tentative Approval to Manufacture and Market Galantamine Tablets on an Exclusive Basis
4. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
5. Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve
6. PainCare Receives $14.4 Million in Cash From Completed Sale of South Florida Ambulatory Surgery Centers
7. UT Southwesterns obesity research receives $22 million NIH Roadmap grant
8. Temple Emergency Medicine receives $1.8M to find best MRSA treatment
9. Prime Therapeutics Receives TIPPS Certification
10. Bioniche Receives $2 Million Government Grant For Market Development Related to its E. coli O157:H7 Cattle Vaccine
11. UCLA receives $22.5 million to explore the fundamental biology of mental disorders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2013)... 24, 2013 IMED Mobility, a premier provider of ... by Nashville recording artist Michelle Murray on Thursday, June 20th 2 ... “My Finish Line” music and movie tour, which shares the story ... crash on the track in 2000. Much of the film takes ... for the sport of INDYCAR racing despite suffering a crash that ...
(Date:5/23/2013)... NY (PRWEB) May 24, 2013 Magnatag’s ... employee absentee patterns and reduces vacation conflicts. A Manufacturing ... problem with vacation conflicts; now employees and managers can ... have any problems. Attendance is important to us and ... are exposed. That may seem harsh but it has ...
(Date:5/23/2013)... Magic often happens unexpectedly. "Howie Goes to ... twin five-year olds, Howie and his sister Heather, at ... in point. May 23, 2013 marks the debut of ... with the start of the Resort's "WeTime/MeTime” program, ... amenities and, most precious of all, opportunities for children and ...
(Date:5/23/2013)... (PRWEB) May 23, 2013 Whether working ... Operations Forces and law enforcement need an added layer ... Security Enhancer, Night VISER , is an effective ... motion sensing system to increase border and perimeter security. ... VISER have more than tripled over the past three ...
(Date:5/23/2013)... On March 14, 2012, Kim Rideout heard the ... her lifetime: she had breast cancer. Her new, candid memoir, ... Cancer Diagnosis ” (published by AuthorHouse), takes readers along with ... her daily journals to give readers a detailed glimpse into ... treatments to deal with stage two breast cancer. She relives ...
Breaking Medicine News(10 mins):Health News:Local Mobility Dealer Hosts Nashville Recording Artist 2Health News:New Attendance, Vacation and Training Tracker Board Reduces Employee Conflicts and Improves Attendance 2Health News:New Children's Comic Book, "Howie Goes to Maui," Launches May 23, 2013 On Four Seasons Resort Maui's Web Site 2Health News:New Children's Comic Book, "Howie Goes to Maui," Launches May 23, 2013 On Four Seasons Resort Maui's Web Site 3Health News:Lighting Up the Night: ARA Announces Record Sales of Its Night VISER System 2Health News:Lighting Up the Night: ARA Announces Record Sales of Its Night VISER System 3Health News:Kimberley Rideout Shares Her Triumphant Cancer Survival Story 2
... handful of top research institutions evaluating a promising new ... of// asthma attacks in inner-city children, a population known ... ,“Children living in inner cities are exposed to ... asthma than children living elsewhere,” said Dr. Rebecca Gruchalla, ...
... university preparing engineers and other professionals, female foeticide and ... up but the Punjab Technical University (PTU) is all ... issues. // ,The campaign by PTU gets underway ... Technology (SVIET) at Banur, 25 km from here. ...
... Martin, a college sophomore, was excited to take Jolene out ... shopping trip to Goodwill Industries, Martin and her sister had ... red dress, // and a black hat that nicely complemented ... part of Jolene was her lifelike rubber ears--connected to an ...
... beginning of a child’s life, parents encourage their children ... This also is an important time to promote healthy ... infant or providing effective treatment for toddlers with eczema, ... together to keep children’s skin clean, healthy and nourished. ...
... study conducted by Queensland University of Technology, women with ... of violence than old age. ,The study, ... of women to protect themselves from violence in old ... the Faculty of Health, said the study looked at ...
... increased risk of suicide according to an Ottawa doctor. ... of Oncology, showed the results of the analysis // of ... Wayne Kendal which revealed that 19 out of every 1,000 ... cancer patients committed suicide. ,The rate of suicides was ...
Cached Medicine News:Health News:New Asthma Medicine Targeting Vulnerable Inner-City Children Tested 2Health News:Kids Help Other Kids to Protect Their Hearing from Personal Music Devices 2Health News:Kids Help Other Kids to Protect Their Hearing from Personal Music Devices 3Health News:Kids Help Other Kids to Protect Their Hearing from Personal Music Devices 4Health News:Kids Help Other Kids to Protect Their Hearing from Personal Music Devices 5Health News:Encouraging a Lifetime of Healthy Skin Right from the Beginning 2Health News:Encouraging a Lifetime of Healthy Skin Right from the Beginning 3Health News:Encouraging a Lifetime of Healthy Skin Right from the Beginning 4Health News:Encouraging a Lifetime of Healthy Skin Right from the Beginning 5Health News:Fear of violence among older women 2Health News:Risk of Suicide in Cancer Patients 2
(Date:5/23/2013)... Hearing health affects a man,s lifestyle, and if he wants ... engaged, he should address any hearing loss he may be ... Hearing Institute (BHI) is delivering to men around the ... which leads up to and includes Father,s Day. This year, ... 16. To help men address their hearing ...
(Date:5/23/2013)... recently published clinical study conducted at TOPS Comprehensive Breast ... that 3D mammography (breast tomosynthesis) significantly reduces unnecessary recalls ... study, "Implementation of Breast Tomosynthesis in a Routine Screening ... Stephen L. Rose , MD, and published in ... Roentgenology (AJR). The AJR is the scientific journal ...
(Date:5/23/2013)... May 23, 2013  Hadasit Bio-Holdings Ltd. (TASE: HDST, ... companies, based on intellectual property developed and owned ... ,s foremost medical research center, today announced that ... significant funding from the Israeli Ministry of Industry ... to support product development and advance clinical trials. ...
Breaking Medicine Technology:Men Who Want to Stay Active, Feel Younger, and Remain Socially and Professionally Engaged Should Address Hearing Loss, BHI Advises 2Men Who Want to Stay Active, Feel Younger, and Remain Socially and Professionally Engaged Should Address Hearing Loss, BHI Advises 3Men Who Want to Stay Active, Feel Younger, and Remain Socially and Professionally Engaged Should Address Hearing Loss, BHI Advises 4First Large-Scale U.S. Study Validates the Benefits of 3D Mammography (Breast Tomosynthesis) Exams 2First Large-Scale U.S. Study Validates the Benefits of 3D Mammography (Breast Tomosynthesis) Exams 3Hadasit Bio-Holdings Ltd. Portfolio Company - Cell Cure Neurosciences Ltd. Received Additional Government Support 2
... Findings Published in June Issue of Circulation , ... United Therapeutics Corporation (Nasdaq: UTHR ) and ... today announced the results of a pivotal 16-week study ... well tolerated, improved exercise capacity and improved time to ...
... Trust for America,s Health (TFAH) and the Robert Wood ... today which finds that Americans rank prevention as the ... increasing funding for prevention programs to reduce disease and ... poll, conducted by Greenberg Quinlan Rosner Research and Public ...
Cached Medicine Technology:Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily 2Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily 3Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily 4Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily 5Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily 6New Poll Finds Disease Prevention is Top Priority for Americans in Health Reform 2New Poll Finds Disease Prevention is Top Priority for Americans in Health Reform 3New Poll Finds Disease Prevention is Top Priority for Americans in Health Reform 4New Poll Finds Disease Prevention is Top Priority for Americans in Health Reform 5
... Triad Skull Clamp, compatible with the full ... of clamping force on all three skull ... the possibility of adjusting the force on ... be increased or decreased by adjusting the ...
A fully automated, benchtop instrument designed for high-volume urine testing, using Siemens' proven technology in dry-pad urine chemistry analysis....
... PocketChem UA is the first ... take up valuable lab bench space. ... the variability in results between operators ... on every run, corrects for ambient ...
... sensor catheters incorporate a lumen ... wire, or high-speed injection/guide wire. ... injection has two laterally opposed ... open-end pigtail extension for use ...
Medicine Products: