Rohm and Haas Brain Cancer Case Tossed Over Expert Report

A brain cancer case against Rohm and Haas was properly thrown out because the testimony of the plaintiff's sole expert on causation was not admissible, the state Superior Court has ruled.

Rohm and Haas Brain Cancer Case Tossed Over Expert Report

A brain cancer case against Rohm and Haas was properly thrown out because the testimony of the plaintiff's sole expert on causation was not admissible, the state Superior Court has ruled.

F.D.A. Approves a Drug for Late-Stage Pancreatic Cancer

In a clinical trial, Abraxane prolonged the lives of patients by a little less than two months on average. Pancreatic specialists have said the drug was a welcome, if modest, advance against a disease that is extremely tough to treat.

“Patients with pancreatic cancer are often diagnosed after the cancer has advanced and cannot be surgically removed,” Dr. Richard Pazdur, director of cancer drugs for the F.D.A., said in a statement on Friday. “In these situations, and in situations where the cancer has progressed following surgery, options like Abraxane can help prolong a patient’s life.”

There will be about 45,000 new cases of pancreatic cancer diagnosed in the United States this year and about 38,000 deaths, making it the fourth-leading cause of cancer death.

Patients with metastatic pancreatic cancer typically live only half a year. For years, researchers have tried to improve that by adding drugs to the standard treatment, gemcitabine, but without notable success.

Abraxane did provide a statistically significant improvement in survival. In its main clinical trial, patients who received Abraxane and gemcitabine lived a median of 8.5 months, compared to 6.7 months for those receiving only gemcitabine.

Abraxane will compete with Folfirinox, a combination of four generic drugs. Folfirinox appears to extend survival by a greater amount than Abraxane, but doctors say it is harder to tolerate and administer.

Abraxane is a novel form of paclitaxel, also known by the brand name Taxol. In Abraxane, the paclitaxel is bound in tiny particles to albumin, a human protein. That is said to enhance delivery of the drug to the tumor and reduce side effects.

Still, Abraxane can depress levels of white blood cells and platelets and raise the risk of bacterial bloodstream infections and lung inflammation, the F.D.A. said.

Abraxane was approved to treat breast cancer in 2005 and lung cancer in 2012. Sales last year were $427 million. Celgene’s total revenue that year was $5.5 billion, mostly from the multiple myeloma drug Revlimid.

Geoffrey Meacham, a biotechnology analyst at J. P. Morgan, said in a note on Friday that he expected Abraxane to “rapidly become the standard of care” for pancreatic cancer. He said sales for that use could eventually exceed $750 million annually.

Celgene said the drug would cost $6,000 to $8,000 a month.

Abraxane was developed by Abraxis BioScience, which Celgene acquired in 2010 for $2.9 billion, in addition to a security entitling holders to possible future payments. With Friday’s approval, Celgene will pay $300 million to those holders.

Cancer Case Remanded for Strict Liability Opinion

The Pennsylvania Superior Court has asked for further explanation from a trial judge on the issue of strict liability in a brain cancer case.

Drug Used to Treat Kidney Cancer May Hold Off Relapses of Ovarian Cancer

CHICAGO — Women with ovarian cancer may be able to stave off relapses for an extra half-year or so by taking a drug already approved to treat kidney cancer, researchers reported here on Saturday. But it will not be clear whether the drug prolongs women’s lives until the patients are followed longer.

The study was one of many being presented at the annual meeting of the American Society of Clinical Oncology.

Another study shows that a drug may have some effect against a rare but notoriously hard to treat form of melanoma.

A third suggests that the spouses or long-term partners of people with mouth or throat cancers linked to human papillomavirus, or HPV, do not have an increased risk of infection from that virus and do not have to change their sexual behaviors.

Ovarian cancer is often successfully controlled initially by surgery and chemotherapy. But about 70 percent of women with advanced ovarian cancer experience a relapse, often in the first year.

The study tested the strategy known as maintenance therapy. Instead of stopping treatment after a tumor is controlled and resuming it only when a cancer starts to worsen, a new drug is given immediately after the successful chemotherapy.

In this study, which involved 940 women with advanced cancer, the maintenance drug was pazopanib, sold as Votrient to treat kidney cancer and soft tissue sarcoma. The trial was sponsored by GlaxoSmithKline, which manufactures Votrient.

For those who received the drug, the median time before the cancer worsened was 17.9 months, compared with 12.3 months for those given a placebo.

“Many patients will experience longer disease-free and chemotherapy-free periods,” said the lead author, Dr. Andreas du Bois, a gynecologic oncologist at the Kliniken Essen-Mitte in Essen, Germany.

GlaxoSmithKline said it would apply for approval of the drug for ovarian cancer. The drug is taken orally and blocks the formation of blood vessels that feed tumors.

Maintenance therapy, however, is controversial because it exposes patients to drug side effects when their cancer is not in evidence. It is also not clear whether the therapy prolongs lives compared with giving that same drug after a relapse.

“These questions do remain as to what is the right drug and what is the right time,” said Dr. Carol Aghajanian, chief of gynecologic medical oncology at the Memorial Sloan-Kettering Cancer Center, who was not involved in the study.

The drug Avastin, sold by Roche, also delays the return of ovarian cancer when used as an initial and maintenance treatment. But in studies, it has not prolonged lives significantly.

Avastin is approved for the treatment of ovarian cancer in Europe but not in the United States.

Another study found that an experimental drug, selumetinib, may be the first to improve the outcome of patients with melanoma that arises in the eye rather than the skin, though the improvement was quite modest.

So-called uveal melanoma is very rare, with about 2,000 new cases a year in the United States.

“We had no options for this group of patients,” said Dr. Lynn M. Schuchter, a melanoma specialist at the University of Pennsylvania, who was not involved in the study. She said the new drug represented an advance.

The drug blocks the activity of a protein called MEK, which often plays a role in spurring cell growth in this type of tumor.

The study involved 98 patients with metastatic uveal melanoma. The median time before the disease worsened was 15.9 weeks for selumetinib, compared with 7 weeks for the control group, which received temozolomide, or Temodar, a drug often used for skin melanoma. Those who received selumetinib lived a median of 10.8 months, compared with 9.4 months for temozolomide, a difference that was not statistically significant. Most patients getting temozolomide switched to selumetinib after their cancer progressed, which could have blunted the difference in survival between the groups.

The drug, which is not yet on the market, is being developed for various cancers by AstraZeneca under license from Array BioPharma. The HPV study involved 166 people with oropharyngeal cancer, a cancer of the mouth and throat, and 94 of their spouses or partners. While HPV is most known as the cause of cervical cancer, it has also been linked to oropharyngeal cancer, which is increasing in incidence and is often caused by having oral sex with someone with a genital infection.

The patients were predominantly men, and all but a handful of the spouses or partners were women. About 5 percent of the female partners had an oral infection with the virus, roughly the same rate as in the general population. Two of the six male partners had an oral infection, but not of the worst type of HPV. That is higher than the general rate for men, but the sample size was too small to draw firm conclusions. Many people get HPV infections but usually clear them.

“Couples who have been together for several years have likely already shared whatever infections they have, and no changes in their physical intimacy are needed,” Gypsyamber D’Souza, the lead study author, said in a statement. She is an associate professor of epidemiology at Johns Hopkins University.

Novelties: In Cancer Treatment, New DNA Tools

Most of these gene flaws — there are scores of them, and they have names like BRAF V600E — are relative newcomers to medical terminology, as are most of the anticancer drugs, still in early testing, that are aimed at them. Development of the new drugs has been spurred by the falling cost of decoding DNA and the prospects of premium prices for drugs that specifically attack the molecular drivers of cancer.

Even medical oncologists can be daunted by the complexity of these genes and the therapies intended to fight them, said Dr. William Pao, a physician and scientist at Vanderbilt University who studies cancer mutations in addition to seeing patients. “There are so many genes and so many mutations,” he said. “The human brain can’t memorize all those permutations.”

To guide doctors and their patients, many tools are on the market, including one created by Dr. Pao and colleagues: the Web site My Cancer Genome. The site, which started two years ago, is maintained by 51 contributors from 20 institutions. It lists mutations in different types of cancer, as well as drug therapies that may or may not be of benefit. Most of the drugs are in clinical trials; a few have been approved by the Food and Drug Administration.

The typical user of this information is an oncologist, Dr. Pao said. At the Web site, the doctor can select “melanoma” and “BRAF,” for instance, or “lung cancer” and “BRAF,” and see all types of mutations in the BRAF gene that occur in those instances. The doctor can then check for national and international drug trials aimed at these alterations.

Different treatments may work in different molecular subsets of cancer, depending on the mutation. More than 700 oncology drugs are now in development, many aimed at DNA defects, Dr. Pao said, “and the number will only accelerate.”

“We are moving away from the tissue of origin to the molecular basis of the cancer, using the mutation to search for a treatment,” he said.

Users do not pay to access the Web site. “Our premise is that much of the discovery work was paid for by taxpayer dollars,” he said, “so the site is public and freely available.” The site is supported almost entirely by the university and by philanthropy.

Before doctors go to My Cancer Genome or a similar site, their patients must have a diagnostic test to find relevant mutations. At one time, such tests were limited mainly to patients at large university cancer centers, and were often hard to interpret, said Dr. Fadi Braiteh, an oncologist who practices at Comprehensive Cancer Centers of Nevada in Las Vegas. Now tests for the mutations and the analyses of the results are available to neighborhood doctors.

In the last four months, Dr. Braiteh has begun using a test, called FoundationOne, from Foundation Medicine in Cambridge, Mass. “In some cases, the test has allowed us to treat with a drug we hadn’t thought of,” he said. The cost is generally covered by insurance, he said; the list price is $5,800. (Dr. Braiteh has no financial connection to Foundation Medicine.)

For the FoundationOne test, the company analyzes a bit of the tumor smaller than a garden pea, extracting the DNA and sequencing genes known to be altered in cancer, said Dr. Michael J. Pellini, president and C.E.O. of Foundation Medicine. Alterations are matched with approved drugs or clinical trials. The treatment options are listed in a report that accompanies the test results. The company began offering its test last year, and it is now used by more than 1,000 doctors, he said, as well as by 15 companies developing cancer drugs.

Dr. Nicholas Koutrelakos, an oncologist who practices at Maryland Oncology Hematology in Columbia, Md., has used the FoundationOne test for the last eight months. “It wasn’t helpful for everyone,” he said, but it did help with four of 10 patients, particularly one with lung cancer who had not responded to chemotherapy. “It gave me some guidance,” he said. “We were able to give a drug we’ve never used before for this mutation.” The patient began taking the drug, and it has been effective so far.

Foundation Medicine, which is privately owned, has financial backing from many sources, including Third Rock Ventures, Google Ventures, Kleiner Perkins Caufield & Byers and private investors like Bill Gates.

Many other genetic tests are coming or are already on the market. Genomic Health, for example, has a test costing $4,290 that helps determine if a woman with breast cancer should receive chemotherapy.

The FoundationOne test concerns itself with a very small subset of the three billion base pairs of DNA in a set of human chromosomes, analyzing the tumor samples for the 236 genes “known to be unambiguously involved in cancer,” a company spokeswoman said. As additional genes are identified, these will be added to the test.

Christopher Milne, director of research at the Tufts Center for the Study of Drug Development at Tufts University, said that there were still many unanswered questions in this field. “There is so much we don’t know about mutations yet,” Dr. Milne said.

Dr. Razelle Kurzrock, director of the center for personalized cancer therapy at the Moores Cancer Center at the University of California, San Diego, says she thinks that comprehensive tests like FoundationOne will be invaluable in the future. “We have to know what’s inside a tumor cell that is causing it to grow,” she said, “and match that knowledge up with the specific drug that targets the abnormality.”

E-mail: novelties@nytimes.com.

Attorney Asks Court to Grant New Trial in Brain Cancer Case

A Philadelphia judge was wrong in entering a compulsory nonsuit in the first of 30 cases over allegations that brain cancers were caused by a carcinogen leaking from a chemical plant, a plaintiff's lawyer argued in front of the state Superior Court on Tuesday.