By MATTHEW PERRONE AP Health Writer
WASHINGTON (AP) - The toxic side effects of an experimental cancer drug from Onyx Pharmaceuticals may outweigh its benefits for patients with a type of blood cancer, federal health regulators said Monday.
The Food and Drug Administration warned that patients in a company study of the drug had a high rate of heart and lung side effects, some which were fatal. The FDA posted its review of carfilzomib online ahead of a meeting Wednesday, where its panel of cancer experts will recommend whether the drug should be approved.
Despite the negative tone of the review, some analysts said they expect the FDA's panel of outside experts to take a more favorable view. FDA panels are mainly comprised of practicing physicians from leading universities and hospitals.
BMO Capital Markets analyst Jim Birchenough said he expects "panel members to be more constructive toward the carfilzomib data package." Birchenough recommended buying the stock, in a note to investors.
Shares of Onyx Pharmaceuticals Inc., based in San Francisco, fell $1.90 to close at $44.08 Monday after rising as high as $46.99 earlier in the session. They are near their 52-week high of $47.80 in late April.
Onyx has asked the FDA to approve carfilzomib as a treatment for patients with advanced forms of multiple myeloma whose disease has spread despite treatment with other drugs.
Multiple myeloma affects plasma cells in bone marrow. Over 50,000 people have the disease in the U.S., and about 20,000 new cases are diagnosed every year.
Onyx studied the drug in 266 patients who had already been treated with two other cancer drugs. About 22 percent of patients studied responded to the drug, with the typical patient surviving slightly less than eight months after beginning treatment. In its briefing, FDA reviewers commented that the response rate was so low "it may not provide an advantage over available therapy."
FDA reviewers said they were also "very concerned with severe toxicities," including heart problems, which affected 23 percent of patients. The agency's scientists said the root cause of those problems "is not understood."
See original here:
Hometownstations.com-WLIO- Lima, OH News Weather SportsFDA focuses on toxic side effects with Onyx drug
- CCHR: Psychiatric Drugs Side Effects - March 14th, 2011 [March 14th, 2011]
- Senseless - March 31st, 2011 [March 31st, 2011]
- Acid Reflux Drug Side-Effects - April 3rd, 2011 [April 3rd, 2011]
- Drug Side Effects Up, But Benefits Up More - April 20th, 2011 [April 20th, 2011]
- OCD Drug Commercial Side Effects Spoof - Funny Obsessive-Compulsive Disorder Cartoon - ExoticJess - May 20th, 2011 [May 20th, 2011]
- Bipolar side effects song Dustin Prinz drugs ep - May 22nd, 2011 [May 22nd, 2011]
- Anti-Malaria Drug Side Effects on Military Personnel - Cowardice - May 23rd, 2011 [May 23rd, 2011]
- The A to Z of Drug Side Effects - June 11th, 2011 [June 11th, 2011]
- Neurologic side effects of antipsychotic medication - June 12th, 2011 [June 12th, 2011]
- Side Effects of Drugs - USE a SAFER Alternative - MD / RN - Click link at RIGHT - June 15th, 2011 [June 15th, 2011]
- Yaz | Yasmin Drug Side Effects - June 16th, 2011 [June 16th, 2011]
- Nutrition vs. Conventional Medicine - June 18th, 2011 [June 18th, 2011]
- Side Effects of Cholesterol Drugs (Lipitor) - June 21st, 2011 [June 21st, 2011]
- CCHR: Drugging Our Children—Side Effects - June 25th, 2011 [June 25th, 2011]
- Side effects of Common Arthritis Drugs.wmv - June 30th, 2011 [June 30th, 2011]
- Self Hypnosis Hallucination Video (NO SIDE EFFECTS) - July 11th, 2011 [July 11th, 2011]
- How Medicines Work: Drug Problems 3: Interactions and Substrates - July 25th, 2011 [July 25th, 2011]
- Pharmaceutical Drug Commercial Spoof - July 26th, 2011 [July 26th, 2011]
- Nick Gillespie Talks Ed Schultz, TSA v. Texas on Fox News Red Eye w/ Greg Gutfeld - July 27th, 2011 [July 27th, 2011]
- The Drugging Of Our Children (Full Length) - August 13th, 2011 [August 13th, 2011]
- HIV medicine ATRIPLA/side effects - August 17th, 2011 [August 17th, 2011]
- What are the side-effects of ADHD medications? - August 26th, 2011 [August 26th, 2011]
- Chemotherapy Cancer Treatments - August 31st, 2011 [August 31st, 2011]
- Suzy Cohen Tells You About Side Effects from Drug Muggers - September 11th, 2011 [September 11th, 2011]
- Governor Admits Past Drug Use, Now What? - September 25th, 2011 [September 25th, 2011]
- Adderall - College Student Smart Drug - September 26th, 2011 [September 26th, 2011]
- Children Drugged To Death - Channel 4 - September 26th, 2011 [September 26th, 2011]
- Mom Refuses Ritalin and Heals Her ADHD Autism Kids With Natural Medicine - September 26th, 2011 [September 26th, 2011]
- Taking the Tablets - Side Effects - September 29th, 2011 [September 29th, 2011]
- Side Effects Of HIV Drugs - September 30th, 2011 [September 30th, 2011]
- Narcotics Agent Body Slams Drug Laws - October 4th, 2011 [October 4th, 2011]
- Most Astonishing Health Disaster of the 20th Century - October 4th, 2011 [October 4th, 2011]
- The Drug EFFEXOR will bring you to your knees - October 4th, 2011 [October 4th, 2011]
- Depakote Side Affects Harm Autistic Person - October 4th, 2011 [October 4th, 2011]
- TV Commercial DruG SPOoF ! - October 4th, 2011 [October 4th, 2011]
- Side Effects - Part 2 - October 4th, 2011 [October 4th, 2011]
- Side Effects May Include... : from the Goin' Green album by: Audio Faux Pas - October 5th, 2011 [October 5th, 2011]
- How to Sue Drug Companies for Free - October 5th, 2011 [October 5th, 2011]
- Should You Trust Your Doctor? - October 5th, 2011 [October 5th, 2011]
- Xenical (Orlistat) Side Effects - News Report - October 5th, 2011 [October 5th, 2011]
- Side Effects - Part 1 - October 5th, 2011 [October 5th, 2011]
- Chantix Side Effects: The Carter Albrecht Effect - October 5th, 2011 [October 5th, 2011]
- Can I sue if a pharmaceutical drug I took causes negative side effects? - October 6th, 2011 [October 6th, 2011]
- Powerful Form of Ecstasy Drug Kills Blood Cancer Cells - 8/21/11 - October 6th, 2011 [October 6th, 2011]
- Drug voltaren - October 6th, 2011 [October 6th, 2011]
- The Dark Side Of Psychiatry--Antipsychotic Drugs, Olanzapine, Risperidone, Clozapine - October 6th, 2011 [October 6th, 2011]
- My Review Of Accutane - October 6th, 2011 [October 6th, 2011]
- Evista treatment - October 6th, 2011 [October 6th, 2011]
- Tizanidine medicine - October 6th, 2011 [October 6th, 2011]
- Ponstel 250mg - October 6th, 2011 [October 6th, 2011]
- #14.2 Senior Medication Challenges - October 6th, 2011 [October 6th, 2011]
- Levlen 28 - October 6th, 2011 [October 6th, 2011]
- Diclofenac uses - October 6th, 2011 [October 6th, 2011]
- Happy Juice - Peru - October 6th, 2011 [October 6th, 2011]
- Premarin pill - October 6th, 2011 [October 6th, 2011]
- Revatio cost - October 7th, 2011 [October 7th, 2011]
- Alendronate sodium pills - October 7th, 2011 [October 7th, 2011]
- Provera drug - October 7th, 2011 [October 7th, 2011]
- Tizanidine drug - October 8th, 2011 [October 8th, 2011]
- CCHR Video 8a - Side Effects. Anti-Depressants, Suicidal Thoughts. Psychotropic Drugs. - October 8th, 2011 [October 8th, 2011]
- Drug Duphaston - October 8th, 2011 [October 8th, 2011]
- Dydrogesterone in Usa - October 8th, 2011 [October 8th, 2011]
- Vigora price - October 8th, 2011 [October 8th, 2011]
- Premarin drug - October 8th, 2011 [October 8th, 2011]
- Raloxifene side effects - October 8th, 2011 [October 8th, 2011]
- Tizanidine medication - October 9th, 2011 [October 9th, 2011]
- Zanaflex drug - October 10th, 2011 [October 10th, 2011]
- Zanaflex medicine - October 10th, 2011 [October 10th, 2011]
- Vigora - October 10th, 2011 [October 10th, 2011]
- Side Effects of Alzheimer's Disease Medications - October 10th, 2011 [October 10th, 2011]
- Are You Tired of Your Blood Pressure Medicine? - October 11th, 2011 [October 11th, 2011]
- PCOS- Metformin (Is it worth dealing with the side effects) - October 12th, 2011 [October 12th, 2011]
- 1/5.Prozac, Zoloft, Paxil, Viagra, Lipitor, Cialis, Nexium - October 12th, 2011 [October 12th, 2011]
- Drug Side Effects - Video - October 13th, 2011 [October 13th, 2011]
- Drug Interactions and Side Effects - Video - October 13th, 2011 [October 13th, 2011]
- Do You Understand Your Prescription Blood Pressure Drugs? - Video - October 13th, 2011 [October 13th, 2011]
- What you need to know about statin drugs side effects (animation) - Video - October 14th, 2011 [October 14th, 2011]
- The #1 Most Dangerous Blood Pressure Drug Side Effect - Video - October 14th, 2011 [October 14th, 2011]
- Mental Health Medication Side Effects - October 14th, 2011 [October 14th, 2011]
- Prescription Drug Side Effects - Video - October 15th, 2011 [October 15th, 2011]